Cleared Traditional

BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (K930302) - FDA 510(k) Clearance

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

K930302 · Birtcher Medical Systems, Inc. · General & Plastic Surgery device
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Oct 1993
Decision
279d
Days
Class 2
Risk

K930302 is an FDA 510(k) clearance for the BIRTCHER SURE CLEAN INSTRUMENT SYSTEM. Classified as Laryngoscope, Endoscope (product code GCI), Class II - Special Controls.

Submitted by Birtcher Medical Systems, Inc. (Duluth, US). The FDA issued a Cleared decision on October 27, 1993 after a review of 279 days - an extended review 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: 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 Birtcher Medical Systems, Inc. devices

Submission Details

510(k) Number K930302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1993
Decision Date October 27, 1993
Days to Decision 279 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
164d slower than avg
Panel avg: 115d · This submission: 279d
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.