Identity
- Trade Name
- Endo Shears FDA UDI
- Generic Name
- Rigid endoscopic scissors, reusable FDA UDI
- Device Name
- Shears FDA UDI
- Model / Reference
- 176643 FDA UDI
- Description
- Shears FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884523000733 FDA UDI
- 510(k) Number
- K951589 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Rigid endoscopic scissors, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDI
Category: Rigid endoscopic scissors, reusable
Endo Shears by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscopic scissors, reusable.
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- ELMED — ELMED INCORPORATED · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Olympus — Olympus Winter & Ibe GmbH · Class II
- ELMED — ELMED INCORPORATED · Class II
Cleared under the same submission
K951589 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI bfff0cd5-6337-40ea-95fe-59ba8475523d 37 fields · synced May 31, 2026