FDA Registration
Active
🇺🇸 United States
Skytron, LLC
Reg #: 1825014
·
FEI: 1825014
·
Expires 2026
Products
24
Proprietary Names
336
Establishment Types
2
Classifications
24
Registration Details
- Registration Name
- Skytron, LLC
- Registration Number
- 1825014
- FEI Number
- 1825014
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5085 Corporate Exchange Blvd SE
- City
- Grand Rapids
- State
- MI
- ZIP
- 49512
- Country
- US
Regulatory Submissions
- 510(k) Number
- K943227
Owner / Operator
- Firm Name
- Skytron, LLC
- Operator Number
- 9918015
- Address
- 5085 Corporate Exchange Blvd SE, --
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49512
- Country
- US
- Correspondent
- Robert - Vreeland
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Television, Surgical, With Audio | FWC | Class 1 | General, Plastic Surgery | No | 2024-10-16 |
| Apparatus, Exhaust, Surgical | FYD | Class 2 | General, Plastic Surgery | No | 2016-05-18 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2007-11-07 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2015-04-22 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2016-05-03 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2019-11-26 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2015-04-22 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2015-04-22 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2015-12-09 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2016-05-03 |
| Warmer, Irrigation Solution | LHC | Class 1 | Physical Medicine | No | 2016-02-17 |
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2015-12-09 |
| Disinfector, Medical Devices | MEC | Class 2 | General Hospital | No | 2015-12-09 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2016-07-18 |
| Armboard, Wheelchair | IMY | Class 1 | Physical Medicine | No | 2017-08-09 |
| Table, Cystometric, Electric | MMZ | Class 2 | Gastroenterology, Urology | No | 2016-04-04 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2020-02-28 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2016-04-04 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2015-05-05 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2017-03-10 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2023-12-11 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2023-01-12 |
| Light, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2015-12-18 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2017-10-31 |
Proprietary Names
VOIRELITE SURGICAL DISPLAY
Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series Aurora Astro Series, DoVera Series, DoVera 2 Series
Lumos Series
Ergon Series Skybooms; Freedom Series Skybooms; Various Models of Skybooms
Shoulder support (pr)
KUB Board
96" restraint strap (velcro fastener)
Angle block adapter for pendant controls
1602 X-ray top set
"L" type anesthesia screen with two adjustable wings, without clamp
Skytron beach chair
Levitator accessory cart kit for use with 6-020-10
E-Z Lift assist beach chair
Shoulder chair accessory cart kit for use with 6-020-10
Radiographic top (3501C)
Anesthesia screen, "wing" type with clamps
Radiolucent standard armboard (without pad)
Transfer board, pin type (6002, 1700, 6700 series & 3600B)
Schure Socket XL
Auxiliary base connector kit (3000)
Radiographic top (6700 series)
Uro drain tray with mounting brackets (6002 & 6700 series)
Radiographic top (1700)
Ortho Trax System
Patient security straps with velcro
Organizer, stirrup kit
Premium locking armboard
Table side extension (3-1/2" x 15" with side rails
Basket accessory cart kit for use with 6-020-10
Clamp on rail
47.5" Nissen strap set
Premium Armboard
Multi-task armboard w/pad (requires clamp) (Sure Clamp 6-040-11 recommended)
Knee/calf ankl-lock crutches with pads and without clamps
Uro drain tray with mounting brackets (3100A)
Organizer, wall mount
General purpose head support
Universal split leg accessory w/2" pad
Flexfit 600 stirrups
Auxiliary base connector kit (3003)
Standard Armboard
40" Carbon fiber extension for 3600B & 6700 series
Heavy duty levitator stirrups, blade type, without clamps, with pads and straps
Instrument tray
Auxiliary base connector installation
12" Carbon fiber arm surgery board for 3000 & 3003 (36" & 48" extensions)
Transfer board pin type (3600B & 6700 series)
Universal side rail clamp II
Auxiliary base connector kit (1700)
Pivoting Carbon fiber clamp-on armboard for 3000 & 3003 (36" & 48" extensions)
Lithotomy stirrups (pr) without clamps
Head end uro tray adapter for crescent type uro metal tray (adapter only)
Narrow head section (6002, 1700, 3600B & 6700 series)
Pediatric Extension
Ankl-lock III lithotomy stirrups without clamps, with pads and straps
58.5" snap restraint strap
Lateral brace for shoulder positioners
Radiographic top for KUB board
Foot control - 3 function (3003) (Trend, tilt, elev)
Adapter to attach 3-040-20 to leg pins
Urology bracket set
105" restraint strap (2 buckles)
OB Hand grips (pr)
Straps for 4-020-02-4 (pr)
Head end uro tray adapter with uro drain tray crescent type (1700, 6002 & 6700 series)
Neuro adapter
Chest and waist support (pr)
Uro drain tray with mounting brackets (3600B)
Foot control - 3 function (6700 series) (Trend, tilt, elev)
Levitator stirrups, blade type, without clamps, with pads and straps
75" patient safety strap (two piece 37"/38")
Nylon restraint belt with velcro
Bar clamp (use with chest and waist supports only)
Split leg section for 6700 series & 3600B
Springloc clamp
Auxiliary base connector kit (3501B)
Carbon Fiber Armboard for 3000 and 3003 (slide under pad type)
Foot rests (pr)
Head end uro tray adapter for rectangular type metal tray (adapter only)
Silhouetted narrow head section (6002, 1700, 3600B & 6700 series) no side rails, includes a 2" pad
Radiographic top (3600B)
Lower back section - 6700 series/3600B (for use with split leg accessory 4-030-61)
96" restraint strap (2 buckles)
EZ-Roll cart
18" foot extension with built in clamps and hd support rod
Tri-clamp - round or flat bar
Raised Armboard without clamp
Prone positioning frame (cloward saddle)
40" carbon fiber accessory kit for use with 6-020-10
Radiographic top (6300)
Catheter extension
Cart, Ortho Trax
18" knee rest
Anesthesia screen "L" type without clamp
Heavy duty support rod for flat bar clamp
Foot Control 3502/6302
10" foot extension without pad
Heavy duty support rod for round bar clamp
Softee strap
EZ grip bar clamp for HD levitators
Beach chair head rest upgrade dual ball joint
5 piece split leg accessory cart kit for use with 6-020-10
Side Rail extension and clamp assembly (7")
Foot Control 3602/6702
Transfer board, side rail type (3100A, 6002, 1700, 6700 series & 3600B)
Standard bar clamp
Angle block installation
2" restraint strap (65" two pieces 42"/23")(1 buckle)
Skytron Urology Bracket
G-Series Light Weight Leg Section
G-Series 44" Carbon Fiber Extension
Versa Fit Bariatric Boot (sold as a pair)
G-Series KUB
Versa Fit Standard Boot (sold as a pair)
G-Series Pediatric Extension
Flex Fit 2
Versa Fit Elite Boot (sold as a pair)
Versa Fit
G-Series Clamp
Skytron Lat Brace "New Style" Red
3-060-08 5 Side Extension
New Style Double Ball Joint Head Section
Sterilizable Handle/Adapter for Various Model Surgical Lights
Sterilizable Camera Cover for Various Model Surgical Lights
Sterilizable Center Focus Handle
Adapter TV light to Center Focus Handle Stellar, Aurora LED and Aurora II Lights
W1 and W2 Series
6702 Hercules, 6302 Elite, 1602 Essentia, 3602 UltraSlide, 3502 EZ Slide, 3003 Impulse
3603 UltraSlide, 3603H UltraSlide, 3503 EZ Slide
3008 Clarity
GS70 SALUS, GS70H SALUS
Stellar Series Surgical Lights
HA60AR/AR24
Spectra AUT1 series
TR-7; HALUX LED 20; Iris LED
Lucina 4
DoVera DE12 Series
Skytron 1602SL 3" SofPad II Pad Set
Skytron 6700 Series 2" SofPad II Pad Set
Skytron Replacement Leg section 3" SofPad II Type C 21.5" long
Skytron 1700 2" SofPad II Pad Set
Skytron Replacement Leg section 3" SofPad II Type A 23.75" long
Skytron 6700 Series 3" SofPad II Pad Set
Skytron 1602SL 4" SofPad II Pad Set
Skytron Replacement Leg section 3" SofPad II Type D 25.5" long
Skytron Replacement Head section 2" SofPad II Type A 9.5" long
Skytron Replacement Leg section 4" SofPad II Type D 25.5" long
Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 2" SofPad II Pad Set
Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 4" Bariatric SofPad II Pad Set
Skytron Replacement Head section 3" SofPad II Type B 12.63" long
Skytron 1602 2" SofPad II Pad Set
Skytron 3000 Series 3" SofPad II Pad Set
Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 2" Bariatric SofPad II Pad Set
Skytron 6300 Series 3" SofPad II Pad Set
Skytron 6700 Series 4" SofPad II Pad Set
Skytron 6300 Series 2" SofPad II Pad Set
Skytron 3000 Series 2" SofPad II Pad Set
Skytron 6300 Series 4" SofPad II Pad Set
2" Welded Seam Pad 18" Foot Extension/Knee Rest
3" 3-piece extra wide Bariatric Sof-Pad set (3600B)
4" 3PC Pad Set 6300 Welded Seam
3" Sof-Pad for Transfer Board (4-030-22)
4" Sof-pad for split leg accessory (right)
4" 3PC Pad Set 6002 Welded Seam
2" 3PC Pad Set 1700 Welded Seam
3" Sof-Pad for radiolucent & premium armboards
4" pad for pivoting carbon fiber armboard
4" 5-piece Sof-Pad set for split leg section
3" 3PC Pad Set 6002 Welded Seam
5" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS
2" Sof-Pad for radiolucent & premium armboards
5" 3PC Pad Set 6700 Series Welded Seam
3" Welded Seam Pad for Pivoting Carbon Fiber Armboard
2" Sof-Pad for 14" Bari Foot Extension
4" 5-piece standard pad set for split leg section
3" 3PC Pad Set 6300 Welded Seam
4" Sof-pad for 5" table side extension (ea.)
3" Standard Pad for Transfer Board (4-030-22)
2" Welded Seam Pad for Pivoting Carbon Fiber Armboard
3" Sof-pad for 3-1/2" table side extensions (ea.)
2" Standard Pad for Transfer Board (4-030-22)
4" Pad for 5" table side extension (ea.)
4" Sof-pad for 10" foot extension
5" Pad 3000/3003 Welded Seam
2" Pad for 12" carbon fiber arm surgery board
4" 3PC Pad Set 1700 Welded Seam
4" Pad for 40" Carbon Fiber Extension
4" Sof-Pad for radiolucent & premium armboards
5" Welded Seam Pad for Pivoting Carbon Fiber Armboard
5" 5-piece Sof-Pad set for split leg section
3" Pad 3000/3003 Welded Seam
2" 3PC Pad Set 6700 Series Welded Seam
5" Sof-Pad for radiolucent & premium armboards
2" Pad for 10" foot extension
2" Sof-pad for 5" table side extension (ea.)
2" Pad for 40" Carbon Fiber Extension
2" Sof-Pad for Carbon Fiber Armboard
2" Sof-pad for 10" foot extension
2" 5-piece Sof-Pad set for split leg section
2" Pad for 5" table side extension (ea.)
5" Sof-pad for 3-1/2" table side extensions (ea.)
4" 3PC Pad Set 6700 Series Welded Seam
Standard Singer Starr Stacker
Knee crutch Sof-Pads (pr.)
5" 3PC Pad Set 6002 Welded Seam
4" Welded Seam Pad 18" Foot Extension/Knee Rest
4" Sof-Pad for 14" Bariatric Foot Extension
2" Sof Pad for Split Leg Foot Rest (4-030-04)
3" 3PC Pad Set 6700 Series Welded Seam
3" Welded Seam Pad 18" Foot Extension/Knee Rest
Singer Starr Stacker Bariatric pad set
5" Sof-pad for 5" table side extension (ea.)
3" Sof-Pad for 14" Bariatric Foot Extension
Singer Starr Leg Stacker
2" pad for 3-1/2" table side extension (ea.)
2" Sof-pad for foot rests (pr.)
2" Pad 3000/3003 Welded Seam
5" Welded Seam Pad 18" Foot Extension/Knee Rest
2" 2PC Pad Set 3100 Welded Seam
4" Sof-Pad for 12" carbon fiber arm surgery board
5" Sof-Pad for 14" Bariatric Foot Extension
3" Sof-pad for 5" table side extension (ea.)
4" Sof-Pad for 40" Carbon Fiber Extension
2" Pad for narrow head section
4" Pad for 10" foot extension
4" Sof-pad for Pelvic tilt seat
2" 3PC Pad Set 6300 Welded Seam
4" Pads for foot rests (pr.)
2" Sof Pad for Transfer Board (4-030-22)
5" 2PC Pad Set 3100 Welded Seam
2" 3PC Pad Set 6002 Welded Seam
4" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM
4" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS
2" pad for radiolucent & premium armboards
2" Sof-pad for 3-1/2" table side extension (ea.)
4" Sof-Pad for Transfer Board (4-030-22)
3" 5-piece Sof-Pad set for split leg section
4" Sof-pad for split leg accessory (left)
2" 3-piece extra wide Bariatric Sof-Pad set (3600B)
3" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS
5" 3PC Pad Set 1700 Welded Seam
5" 3PC Pad Set 6300 Welded Seam
4" Standard Pad for Transfer Board (4-030-22)
3" 2PC Pad Set 3100 Welded Seam
4" 2PC Pad Set 3100 Welded Seam
3" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM
2" 5-piece standard pad set for split leg section
3" 3-3/4" 5pc. Standard Pad Set Split Leg
2" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM
2" 3PC PAD SET: 3501B, 3501C, 3502, 3503, 3600 SERIES WELDED SEAMS
2" Sof-pad for split leg accessory (right)
2" Sof-pad for split leg accessory (left)
4" Pad for narrow head section
5" STANDARD OR RADIOLUCENT ARMBOARD PAD WELDED SEAM
4" Pad for 3-1/2" table side extension (ea.)
3" 3PC Pad Set 1700 Welded Seam
4" pad for radiolucent & premium armboards
4" Welded Seam Pad for Pivoting Carbon Fiber Armboard
5" 5-piece standard pad set for split leg section
2" pad for pivoting carbon fiber armboard
4" Sof-pad for 3-1/2" table side extension (ea.)
4" Pad 3000/3003 Welded Seam
2" Sof-Pad for 40" Carbon Fiber Extension
Pad Left Panel
Pad Main Body
Pad Right Panel
S.C. Head Pad D
Skytron Replacement Head section 3" SofPad II Type A 9.5" long
Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 4" SofPad II Pad Set
Skytron 6700 Series 3" Bariatric SofPad II Pad Set
Skytron Replacement Leg section 2" SofPad II Type A 23.75" long
Skytron Replacement Leg section 2" SofPad II Type D 25.5" long
Skytron 3000 Series 4" SofPad II Pad Set
Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 3" Bariatric SofPad II Pad Set
Skytron Replacement Head section 2" SofPad II Type B 12.63" long
Skytron 1700 3" SofPad II Pad Set
Skytron Replacement Leg section 4" SofPad II Type A 23.75" long
Skytron 1700 4" SofPad II Pad Set
Skytron Replacement Leg section 2" SofPad II Type C 21.5" long
Skytron 1602 3" SofPad II Pad Set
Skytron Replacement Leg section 4" SofPad II Type C 21.5" long
Skytron 6700 Series 4" Bariatric SofPad II Pad Set
Pad Lateral Brace
Skytron 3501B, 3501C, 3502, 3503, 3600, GS70, GS50 3" SofPad II Pad Set
Skytron 6700 Series 2" Bariatric SofPad II Pad Set
Skytron Replacement Head section 4" SofPad II Type B 12.63" long
Pad Lateral Brace Curved
Skytron 1602 4" SofPad II Pad Set
Skytron Replacement Head section 4" SofPad II Type A 9.5" long
Skytron 1602SL 2" SofPad II Pad Set
Nautilus LED series
Stellar XL Series
Remote Camera Control Unit Aurora II and newer, Camera for Aurora 3 and Aurora 4 and Lumos Series, Camera for DoVera DM5
Optik View 31" Display
Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Sterilizer
CleanStart
Flex Surgical Instrument Washer
Skytron I3; Skytron I5; Sterling Washer P1500, P1000, P1800
C2000-E480
C2000LW-E480
C2000-E208
C2000W-E480
C2000-S480
C2000LW-S480
C2000W-S208
C2000W-S480
C2000L-S208
C2000LW-S208
Sterling C2000 Series Cart Washer
C2000W-E208
C2000L-E208
C2000-S208
C2000L-E480
C2000L-S480
C2000LW-E208
Skytron Carter Hand Surgery Table (Case)
UroCatcher II Sterile Disposable Pouch
Urology Bracket Set
Sterile Cover for joystick of 3000 Series Tables
Skytron Disposable Light Handle Cover
Surgical Light Control
Cleanview disposable handle cover
Ascend Video Integration
ESU Pencil Adapter
Skytron Integrity 175 Steam Sterilizer; Skytron Integrity 175SG Steam Sterilizer
SkyVision series, H1, H2, LINX, Ascend Video Integration
SkyVision SDS
SMOKE-E-VAC
Sterile drape for Argos control wand
Skytron Integrity 215 Steam Sterilizer; Skytron Integrity 215SG Steam Sterilizer
Streamline
Flex CT6
ASCEND IP
Aurora 2 Series; Aurora 3 Series; Aurora 4 Series; Aurora Series; Nautilus LED Series; Stellar Series; Stellar XL Series
Aurora Astro Series, DoVera Series
URO TRAY REPLACEMENT HOSE FLEX TYPE (10 PER BAG)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility