Cleared Traditional

K871057 - MC-SERIES SURGICAL CAMERAS

K871057 is an FDA 510(k) clearance for MC-SERIES SURGICAL CAMERAS, manufactured by M.P. Video, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FWB cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K871057 · M.P. Video, Inc. · General & Plastic Surgery device
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Apr 1987
Decision
17d
Days
Class 1
Risk

K871057 is an FDA 510(k) clearance for the MC-SERIES SURGICAL CAMERAS. Classified as Camera, Television, Surgical, Without Audio (product code FWB), Class I - General Controls.

Submitted by M.P. Video, Inc. (North Attleboro, US). The FDA issued a Cleared decision on April 3, 1987 after a review of 17 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 - K871057

510(k) Number K871057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1987
Decision Date April 03, 1987
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

FWB Device Classification - Class 1, General Controls

Product Code FWB Camera, Television, Surgical, 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.