Identity
- Trade Name
- Slimline FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Semi-Rigid Alligator Grasping Forceps 5 Fr, (1.67mm), 42 CM FDA UDI
- Model / Reference
- GYA-5 FDA UDI
- Description
- Semi-Rigid Alligator Grasping Forceps 5 Fr, (1.67mm), 42 CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925002470 FDA UDI
- 510(k) Number
- K890328 FDA UDI
- FDA Product Code
- FAS FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 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
Category: Rigid endoscopic tissue manipulation forceps, reusable
Slimline by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- HYSAFE — Richard Wolf GmbH · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Slide n Lock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
Cleared under the same submission
K890328 also covers:
- Blue Silicone — Gyrus Acmi, Inc.
- Elite 2 System — Gyrus Acmi, Inc.
- Elite 2 System — Gyrus Acmi, Inc.
- Elite 2 System — Gyrus Acmi, Inc.
- Elite 2 System — Gyrus Acmi, Inc.
- Elite 2 System — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 5f370f48-c4a7-4735-8f65-974b2ccb7633 34 fields · synced May 31, 2026