Cleared Traditional

K932987 - BIRTCHER LAPAROSCOPE AND ACCESSORIES

K932987 is an FDA 510(k) clearance for BIRTCHER LAPAROSCOPE AND ACCESSORIES, manufactured by Birtcher Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K932987 · Birtcher Medical Systems, Inc. · General & Plastic Surgery device
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Apr 1994
Decision
311d
Days
Class 2
Risk

K932987 is an FDA 510(k) clearance for the BIRTCHER LAPAROSCOPE AND ACCESSORIES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Birtcher Medical Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on April 25, 1994 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K932987

510(k) Number K932987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1993
Decision Date April 25, 1994
Days to Decision 311 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
196d slower than avg
Panel avg: 115d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GCJ Laparoscope, General & Plastic Surgery

All 1094
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K932987.
CONMED MODULAR DESIGN ELECTROSURGICAL LAPROSCOPY INSTRUMENTS
K934916 · Conmedcorp · May 1994
ADJUSTABLE BALLOON DISSECTION CANNULA
K940875 · Origin Medsystems, Inc. · May 1994
MURDOCH INTRAOPERATIVE LAPAROSCOPIC LENS CLEANER
K935754 · Cook Urological, Inc. · May 1994
INSULATED FORCEPS, BIOPSY FORCEPS, SCISSORS
K935071 · KARL STORZ Endoscopy-America, Inc. · Apr 1994
APPENDIX EXTRACTOR 8385.50
K940900 · Richard Wolf Medical Instruments Corp. · Apr 1994
TISSUE ISOLATION AND RETRIEVAL BAG
K941500 · Advanced Surgical, Inc. · Apr 1994