0 Deg 4mm AC Arthroscope

FDA UDI

Class II (US FDA UDI)

by Poc

Identity

Trade Name: 0 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: 5250-902 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: 00856164008198 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Rigid optical arthroscope, reusable

0 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:

30 Deg 4mm AC Arthroscope — Poc

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 d406c182-6fd9-4cc4-8acf-507d89ccb9cd 34 fields · synced May 30, 2026