Cleared Traditional

K875004 - PRISMA DISPOS. BRITE LITE FIBEROPTIC EN...

K875004 is the FDA 510(k) clearance for PRISMA DISPOS. BRITE LITE FIBEROPTIC EN... 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 101-day FDA review.

K875004 · Advanced Surgical Products, Inc. · General & Plastic Surgery device
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Mar 1988
Decision
101d
Days
Class 2
Risk

K875004 is an FDA 510(k) clearance for the PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on March 14, 1988 after a review of 101 days - within the typical 510(k) review window.

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: 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 Advanced Surgical Products, Inc. devices

Submission Details

510(k) Number K875004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1987
Decision Date March 14, 1988
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
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 K875004.
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K003577 · STERIS Corporation · Jan 2001
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544 · Kirschner Medical Corp. · Aug 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274 · Pentax Precision Instrument Corp. · Jan 1992
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