Cleared Traditional

K936114 - BIRTCHER PERICARDIAL KNIVES

K936114 is an FDA 510(k) clearance for BIRTCHER PERICARDIAL KNIVES, 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 439-day FDA review.

K936114 · Birtcher Medical Systems, Inc. · General & Plastic Surgery device
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Apr 1994
Decision
439d
Days
Class 2
Risk

K936114 is an FDA 510(k) clearance for the BIRTCHER PERICARDIAL KNIVES. 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 439 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Birtcher Medical Systems, Inc. devices

FDA 510(k) Submission Details - K936114

510(k) Number K936114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1993
Decision Date April 25, 1994
Days to Decision 439 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
324d slower than avg
Panel avg: 115d · This submission: 439d
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 K936114.
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
AESCULAP TROCAR COLLAR
K941024 · Aesculap, Inc. · Apr 1994