Cleared Traditional

K882924 - MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS

K882924 is an FDA 510(k) clearance for MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS, manufactured by M.P. Video, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KQM cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K882924 · M.P. Video, Inc. · General & Plastic Surgery device
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Jul 1988
Decision
13d
Days
Class 1
Risk

K882924 is an FDA 510(k) clearance for the MEDICAM MC-7 AND RP-7 SURGICAL CAMERAS. Classified as Camera, Surgical And Accessories (product code KQM), Class I - General Controls.

Submitted by M.P. Video, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 26, 1988 after a review of 13 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all M.P. Video, Inc. devices

FDA 510(k) Submission Details - K882924

510(k) Number K882924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1988
Decision Date July 26, 1988
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

KQM Device Classification - Class 1, General Controls

Product Code KQM Camera, Surgical And Accessories
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 - KQM Camera, Surgical And Accessories

Devices cleared under the same product code (KQM) and FDA review panel - the closest regulatory comparables to K882924.
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