Cleared Traditional

K870942 - MVS FIBEROPTIC LIGHTPIPE

K870942 is the FDA 510(k) clearance for MVS FIBEROPTIC LIGHTPIPE by Advanced Surgical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code FST) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K870942 · Advanced Surgical Products, Inc. · General & Plastic Surgery device
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Apr 1987
Decision
25d
Days
Class 2
Risk

K870942 is an FDA 510(k) clearance for the MVS FIBEROPTIC LIGHTPIPE. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Charles, US). The FDA issued a Cleared decision on April 3, 1987 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 Advanced Surgical Products, Inc. devices

Submission Details

510(k) Number K870942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1987
Decision Date April 03, 1987
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FST Light, Surgical, Fiberoptic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FST Light, Surgical, Fiberoptic

All 15
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K870942.
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875005 · Advanced Surgical Products, Inc. · Mar 1988
PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875006 · Advanced Surgical Products, Inc. · Mar 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875007 · Advanced Surgical Products, Inc. · Mar 1988
HEADLIGHTS W/ FILTER-OPTICO CABLES
K761142 · Pilling Co. · Jan 1977