Cleared Traditional

GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (K930496) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930496 · Birtcher Medical Systems, Inc. · General & Plastic Surgery device
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Apr 1993
Decision
78d
Days
Class 2
Risk

K930496 is an FDA 510(k) clearance for the GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS. Classified as Laryngoscope, Endoscope (product code GCI), Class II - Special Controls.

Submitted by Birtcher Medical Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Birtcher Medical Systems, Inc. devices

Submission Details

510(k) Number K930496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date April 20, 1993
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCI Laryngoscope, Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.