Cleared Traditional

K875006 - PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK

K875006 is an FDA 510(k) clearance for PRISMA DISPOSA. BRITE LITE FIBEROPTIC E..., manufactured by Advanced Surgical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K875006 · Advanced Surgical Products, Inc. · General & Plastic Surgery device
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Mar 1988
Decision
101d
Days
Class 2
Risk

K875006 is an FDA 510(k) clearance for the PRISMA DISPOSA. 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

FDA 510(k) Submission Details - K875006

510(k) Number K875006 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.

FST Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K875006.
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K893491 · Cuda Products Co. · Jun 1989
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875004 · Advanced Surgical Products, Inc. · Mar 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875005 · Advanced Surgical Products, Inc. · Mar 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875007 · Advanced Surgical Products, Inc. · Mar 1988
MVS FIBEROPTIC LIGHTPIPE
K870942 · Advanced Surgical Products, Inc. · Apr 1987
HEADLIGHTS W/ FILTER-OPTICO CABLES
K761142 · Pilling Co. · Jan 1977