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
Camera, Television, Surgical, With Audio FWC
Apparatus, Exhaust, Surgical FYD
Light, Surgical, Ceiling Mounted FSY
Table, Operating-Room, Ac-Powered FQO
Light, Surgical, Accessories FTA
Warmer, Thermal, Infusion Fluid LGZ
Table, Operating-Room, Electrical GDC
Device, Medical Examination, Ac Powered KZF
Surgical Table Cushion LWG
Camera, Surgical And Accessories KQM
Warmer, Irrigation Solution LHC
Sterilizer, Steam FLE
Disinfector, Medical Devices MEC
Tubing, Noninvasive GAZ
Armboard, Wheelchair IMY
Table, Cystometric, Electric MMZ
Drape, Surgical, Exempt PUI
System, Image Processing, Radiological LLZ
System, Digital Image Communications, Radiological LMD
Stand, Infusion FOX
Cleaner, Ultrasonic, Medical Instrument FLG
Medical Device Data System OUG
Light, Surgical, Floor Standing FSS
Bag, Urine Collection, Leg, For External Use, Non-Sterile NNW

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