Cleared Traditional

K982965 - ENDOCAM CAMERA SYSTEMS 5502/5507 WITH C...

K982965 is the FDA 510(k) clearance for ENDOCAM CAMERA SYSTEMS 5502/5507 WITH C... by Richard Wolf Medical Instruments Corp.. It is a Class 1 General & Plastic Surgery device (product code FWF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982965 · Richard Wolf Medical Instruments Corp. · General & Plastic Surgery device
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Nov 1998
Decision
90d
Days
Class 1
Risk

K982965 is an FDA 510(k) clearance for the ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES. Classified as Camera, Television, Endoscopic, Without Audio (product code FWF), Class I - General Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on November 23, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4160 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K982965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1998
Decision Date November 23, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FWF Camera, Television, Endoscopic, Without Audio
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FWF Camera, Television, Endoscopic, Without Audio

Devices cleared under the same product code (FWF) and FDA review panel - the closest regulatory comparables to K982965.
VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10
K930053 · Medical Devices, Inc. · May 1993
THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM
K881014 · KARL STORZ Endoscopy-America, Inc. · Apr 1988
RGB CAMERA SYSTEM
K872661 · Aspen Laboratories, Inc. · Jul 1987
VIDEO CAMERA SYSTEM
K863598 · American Edwards Laboratories · Oct 1986
ARTHROSCAN VIDEO SYSTEM
K834069 · Concept, Inc. · Jan 1984