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AED FB3951-3 Flexible Biopsy Cup Grasper, 1.6mm x 220cm, 5FR
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AED FB3951-3 Flexible Biopsy Cup Grasper, 1.6mm x 220cm, 5FR FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- FB3951-3 Flexible Biopsy Cup Grasper, 1.6mm x 220cm, 5FR FDA UDI
- Model / Reference
- FB3951-3 FDA UDI
- Description
- FB3951-3 Flexible Biopsy Cup Grasper, 1.6mm x 220cm, 5FR FDA UDI
Identifiers
- Catalog Number
- FB3951-3 FDA UDI
- Primary DI / UDI-DI
- 00848657075091 FDA UDI
- 510(k) Number
- K141515 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid endoscopic tissue manipulation forceps, reusable
AED FB3951-3 Flexible Biopsy Cup Grasper, 1.6mm x 220cm, 5FR by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
- HYSAFE — Richard Wolf GmbH · Class II
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- CLICKLINE — Karl Storz GmbH & Co. KG · Class II
- Endoplus — Endoplus · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class II
- ReNew — MICROLINE SURGICAL, INC. · Class II
Cleared under the same submission
K141515 also covers:
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
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
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 4d5d5694-3322-4734-a6f6-ceca33b050fc 36 fields · synced May 30, 2026