Cleared Traditional

K930302 - BIRTCHER SURE CLEAN INSTRUMENT SYSTEM

K930302 is an FDA 510(k) clearance for BIRTCHER SURE CLEAN INSTRUMENT SYSTEM, manufactured by Birtcher Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCI cleared through the Traditional 510(k) pathway after a 279-day FDA review.

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

FDA 510(k) Submission Details - K930302

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.

GCI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GCI Laryngoscope, Endoscope

All 8
Devices cleared under the same product code (GCI) and FDA review panel - the closest regulatory comparables to K930302.
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K003222 · Computer Motion, Inc. · Nov 2000
AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH
K922123 · United States Surgical, A Division of Tyco Healthc · Feb 1993
GLEESON CLOT-BUSTER
K920139 · Conmedcorp · Apr 1992
POOLE TIP SUCTION PROBE
K915762 · O.R. Concepts, Inc. · Mar 1992
SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
K914120 · Conmedcorp · Oct 1991
ENDOSTAPLE
K911829 · Ethicon, Inc. · Aug 1991