Identity
- Trade Name
- Endoscopic Biopsy Forceps FDA UDI
- Generic Name
- Flexible endoscopic scissors, reusable FDA UDI
- Device Name
- FORCEPS 3221-002 BIOPSY 2MM L 19.7CM FDA UDI
- Model / Reference
- 3221-002 FDA UDI
- Description
- FORCEPS 3221-002 BIOPSY 2MM L 19.7CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169497757 FDA UDI
- 510(k) Number
- K945633 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Flexible endoscopic scissors, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Flexible endoscopic scissors, reusable
Endoscopic Biopsy Forceps by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic scissors, reusable.
- Scissors — SOPRO-COMEG GmbH · Class II
- ELMED — ELMED INCORPORATED · Class I
- Vasoview VV6 Pro — Maquet Cardiovascular LLC · Class II
- ELMED — ELMED INCORPORATED · Class I
- Gyrus ACMI — Gyrus Acmi, Inc. · Class I
- ELMED — ELMED INCORPORATED · Class I
- HYSAFE — Richard Wolf GmbH · Class II
- ELMED — ELMED INCORPORATED · Class I
Cleared under the same submission
K945633 also covers:
- ChannelScope — CLARUS MEDICAL, LLC
- ChannelScope — CLARUS MEDICAL, LLC
- ChannelScope, Long, 10K — CLARUS MEDICAL, LLC
- Edoscopic Dissection Probe — Medtronic PS Medical
- Edoscopic Dissection Probe — Medtronic PS Medical
- Edoscopic Dissection Probe — Medtronic PS Medical
- Edoscopic Dissection Probe — Medtronic PS Medical
- Endoscopic Biopsy Forceps — Medtronic PS Medical
- Endoscopic Biopsy Forceps — Medtronic PS Medical
- Endoscopic Biopsy Forceps — Medtronic PS Medical
- Endoscopic Biopsy Forceps — Medtronic PS Medical
- Endoscopic Scissors — Medtronic PS Medical
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic PS Medical
Sources (1)
- FDA UDI a1c8842a-8449-46d6-b082-707321a9a107 35 fields · synced May 31, 2026