Identity
- Trade Name
- 30 Deg 4mm AC Arthroscope FDA UDI
- Generic Name
- Rigid optical arthroscope, reusable FDA UDI
- Device Name
- The POC endoscope is intended use for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with endoscopic instrument control systems during laparoscopic and thoracoscopic surgical procedures. FDA UDI
- Model / Reference
- 5250-901 FDA UDI
- Description
- The POC endoscope is intended use for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with endoscopic instrument control systems during laparoscopic and thoracoscopic surgical procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856164008181 FDA UDI
- 510(k) Number
- K945684 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Rigid optical arthroscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Rigid optical arthroscope, reusable
30 Deg 4mm AC Arthroscope by Poc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical arthroscope, reusable.
- Arthrex® — Arthrex, Inc. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Precision Ideal Eyes — Stryker Corp. · Class II
Cleared under the same submission
K945684 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
- Poc
Sources (1)
- FDA UDI 1ed47765-6c65-4d96-ad9d-31d9f0e46274 34 fields · synced Jun 6, 2026