Cleared Traditional

K932779 - BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.

K932779 is an FDA 510(k) clearance for BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBE..., manufactured by Birtcher Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 651-day FDA review.

K932779 · Birtcher Medical Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
651d
Days
Class 2
Risk

K932779 is an FDA 510(k) clearance for the BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Birtcher Medical Systems, Inc. (El Paso, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 651 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology submissions.

View all Birtcher Medical Systems, Inc. devices

FDA 510(k) Submission Details - K932779

510(k) Number K932779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1993
Decision Date March 21, 1995
Days to Decision 651 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
491d slower than avg
Panel avg: 160d · This submission: 651d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 228
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K932779.
AESCULAP LAPAROSCOPES
K942730 · Aesculap, Inc. · Apr 1995
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
K945211 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
K943603 · Aesculap, Inc. · Mar 1995
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
K945982 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
LAPAROSCOPE AND ACCESSORIES FOR OB/GYN
K950232 · Olympus America, Inc. · Mar 1995
CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020
K932276 · KARL STORZ Endoscopy-America, Inc. · Feb 1995