Logic Hd camera head green, System green
by Richard Wolf Medical Instruments Corporation 510(k)
Active
510(k) K212808
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212808 | Date14 Jun 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
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
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.