FDA Registration
Active
🇺🇸 United States
Covidien
Reg #: 2647580
·
FEI: 2647580
·
Expires 2026
Products
27
Proprietary Names
107
Establishment Types
3
Classifications
27
Registration Details
- Registration Name
- Covidien
- Registration Number
- 2647580
- FEI Number
- 2647580
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BUILDING 911-67, SABANETAS INDUSTRIAL PARK
- City
- PONCE
- State
- PR
- ZIP
- 00731
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231491
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2023-09-19 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2023-09-19 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2007-12-10 |
| Trocar, Gastro-Urology | FBQ | Class 2 | Gastroenterology, Urology | No | 2007-04-24 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2008-01-02 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2007-12-10 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 1997-12-04 |
| Forceps, Obstetrical | HDA | Class 2 | Obstetrics/Gynecology | No | 2007-04-24 |
| Apparatus, Suturing, Stomach And Intestinal | FHM | Class 1 | General, Plastic Surgery | No | 2007-04-24 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2014-10-24 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 1997-12-04 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 1994-07-11 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2007-12-10 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1997-03-20 |
| Device, Occlusion, Umbilical | FOD | Class 1 | General Hospital | No | 2005-09-12 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1996-10-25 |
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2016-02-19 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2019-09-18 |
| Accessories, Cleaning, For Endoscope | FEB | Class 2 | Gastroenterology, Urology | No | 2007-04-24 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2007-12-13 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2007-12-10 |
| Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | KDW | Class 1 | Pathology | No | 1994-04-11 |
| Motor, Surgical Instrument, Pneumatic Powered | GET | Class 1 | General, Plastic Surgery | No | 2007-04-24 |
| Applier, Staple, Surgical, | GEF | Class 1 | General, Plastic Surgery | No | 2007-12-10 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2007-04-24 |
| Endoscopic Tissue Approximation Device | OCW | Class 2 | Gastroenterology, Urology | No | 2009-08-12 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2007-12-10 |
Proprietary Names
TA Stapler and Loading Unit with DST Series Technology
ENDO BAG
ENDO GIA ROTICULATOR Staplers
ILAN
SURGIPORT SPIRAL SLEEVE
ILA GIA Staplers
ROTICULATOR ENDO MINI-SHEARS
Purstring
Versastep V2
ENDO SHEARS
Radial Expandable
Laparoscope
Endo GIA Pancreas Indication
Spacemaker Balloon Dissector
EndoSaph Vein Harvest System
Versaport RPF
Surgiport
EEA Surgical Stapler
GIA Stapler with Tri-Staple Technology
Surgiwand II
ENDO CLOSE
AUTOSUTURE ENDOSCOPIC CLAMP
Blunt Tip Trocars
VERSAPORT
ArthroPort
VERSASEAL
GIA PREMIUM
EEA Circular Stapler with DST Series Technology
Extra View Sterile Balloons
Clearify
Premium Surgiclip
SURGINEEDLE
Endo Universal 65
POLY GIA
EEA Circular Stapler with Tri-Staple Technology
FRED
ENDO MINI-SHEARS
Open Step
ENDO PEANUT
ENDO PADDLE RETRACT
Versaport
Umbilical Tape
EEA
Circular Stapler with Tri-Staple
Transoral Circular Stapler Anvil
Technology and OrVil
ACUCLIP
GIATM Stapler with Tri-StapleTM Technology
SURGICAL DYNAMICS
SURGICAL DYNAMICS*
One Step
EEA Circular Stapler with Tri-Staple Technology
Thoracoport
Auto Suture
Suture Convenience Kit
ReliaMax
ENDO SLIDE
Clearify Trocar Wipe
BLUNTGRIP - SURGIGRIP
Spacekeeper
ANTI-FOG
Versaport V2
Endo GIA Reloads with Tri-Staple Technology
Signia Small Diameter Reloads
Tri-staple 2 Reloads
Endo GIA Gray Articulating Reloads
EEA'M Circular Stapler with Tri-Staple" Technology
Versaport Bladeless
Visiport
EEA Stapler
General Non-Sterile Surgical Inst
PDB Sterile Balloon
Step
PDB
AUTO SUTURE ENDO CATCH SPECIMAN BAG
GIA Auto Suture Stapler with DST Series Technology, GIA Auto Suture
ENDO LUNG
Premium-SurgiClip III
Surgiclip"
Endo Lube
ILA, EEA, LDS reusable staplers
SPACEMAKER
MINI STEP
SURGIPORT
SURGIWAND
Tacker System
Absorbatack
STAT Tack
Protack
Minisite Bipolar Forceps
ROTICULATOR ENDO DISSECT - ENDO GRASP
ENDO MINI-RETRACT
CLIP IMPLANTABLE
MULTAPPLIER
TriMax
IO+ Port
Clip Applier
VersaOne Bladeless Trocar
ENDO TA
Premium Mulitfire TA
SFS Stapler
McKesson Skin Staplers 35 REGULAR
Appose Skin Staplers
Signet
McKesson Skin Staplers 35 WIDE
ConcordeMultifire Premium skin stapler
Versastep
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility