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Logic Hd camera head green, System green

by Richard Wolf Medical Instruments Corporation 510(k)

Active United States

510(k) K212808

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212808 Date14 Jun 2022ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FET
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An Endoscopic Video Imaging System/Component used in Gastroenterology and Urology specialties. It is a camera head designed for endoscopic video imaging.

Supplied as a reusable device for use in clinical settings. Authorized under FDA 510(k) clearance K212808, classified as Class II under regulation number 876.1500.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Logic Hd camera head green used for?

    The Logic Hd camera head green is an endoscopic video imaging system component designed for use in gastroenterology and urology specialties to capture video during endoscopic procedures.

  • Is the Logic Hd camera head green a reusable or single-use device?

    The Logic Hd camera head green is supplied as a reusable device intended for multiple uses in clinical settings after proper cleaning and reprocessing according to manufacturer instructions.

  • How is the Logic Hd camera head green supplied and what is its regulatory status?

    The Logic Hd camera head green is supplied as a reusable endoscopic video imaging system component and is authorized under FDA 510(k) clearance K212808, classified as a Class II medical device under regulation 876.1500.