Cleared Traditional

K211332 - D Camera Controller

K211332 is an FDA 510(k) clearance for D Camera Controller, manufactured by Richard Wolf Medical Instruments Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K211332 · Richard Wolf Medical Instruments Corporation · Gastroenterology & Urology device
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Oct 2021
Decision
151d
Days
Class 2
Risk

K211332 is an FDA 510(k) clearance for the D Camera Controller. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corporation (Vernon Hills, US). The FDA issued a Cleared decision on October 1, 2021 after a review of 151 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard Wolf Medical Instruments Corporation devices

FDA 510(k) Submission Details - K211332

510(k) Number K211332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date October 01, 2021
Days to Decision 151 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 130d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 61
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K211332.
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
K222584 · Olympus Medical Systems Corporation · Apr 2023
Logic Hd camera head green, System green
K212808 · Richard Wolf Medical Instruments Corporation · Jun 2022
Telepack +
K221174 · KARL STORZ Endoscopy-America, Inc. · May 2022
Visera Elite II Video System Center
K202646 · Olympus Medical Systems Corp. · Oct 2020
Image1 S CCU, Image1 S 4U Camera Head
K201135 · KARL STORZ Endoscopy-America, Inc. · Sep 2020
Visera Elite II Video System Center
K201200 · Olympus Medical Systems Corp. · Jul 2020