Cleared Traditional

K931654 - BIRTCHER MAGNETIC RETRIEVER (GS-3100)

K931654 is an FDA 510(k) clearance for BIRTCHER MAGNETIC RETRIEVER (GS-3100), 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 385-day FDA review.

K931654 · Birtcher Medical Systems, Inc. · Obstetrics & Gynecology device
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Apr 1994
Decision
385d
Days
Class 2
Risk

K931654 is an FDA 510(k) clearance for the BIRTCHER MAGNETIC RETRIEVER (GS-3100). Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), 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 385 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Birtcher Medical Systems, Inc. devices

FDA 510(k) Submission Details - K931654

510(k) Number K931654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date April 25, 1994
Days to Decision 385 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
225d slower than avg
Panel avg: 160d · This submission: 385d
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 K931654.
KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS
K940049 · Baxter Healthcare Corp · May 1994
MYOMA DRILL 5MM-8383.611
K940844 · Richard Wolf Medical Instruments Corp. · May 1994
ENDOSCOPE
K925968 · United States Surgical, A Division of Tyco Healthc · Apr 1994
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS
K923259 · Imtec Corp. · Apr 1994
NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE
K926021 · Zinnanti Surgical Instruments, Inc. · Apr 1994
ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET
K932118 · Core Dynamics, Inc. · Mar 1994