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Endoscopic Biopsy Forceps
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K953962
Identity
- Trade Name
- Endoscopic Biopsy Forceps FDA UDI
- Generic Name
- Flexible endoscopic scissors, reusable FDA UDI
- Device Name
- FORCEPS 3221-001 BIOPSY 3MM L 19.7CM FDA UDI
- Model / Reference
- 3221-001 FDA UDI
- Description
- FORCEPS 3221-001 BIOPSY 3MM L 19.7CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169498037 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_510K — listed in FDA GUDID, FDA 510(k) — 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 Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K953962 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic PS Medical
- FDA Applicant
- Biopsys Medical, Inc.
Sources (2)
- FDA UDI eda66568-305e-45fc-a784-b18693fa31b8 59 fields · synced Jun 18, 2026
- FDA 510(k) K953962 1 fields · synced May 25, 2026