Cleared Traditional

K953548 - LAPAROSCOPIC SURGICAL INSTRUMENT

K953548 is an FDA 510(k) clearance for LAPAROSCOPIC SURGICAL INSTRUMENT, manufactured by Gabris Surgical Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K953548 · Gabris Surgical Corp. · Obstetrics & Gynecology device
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Sep 1995
Decision
53d
Days
Class 2
Risk

K953548 is an FDA 510(k) clearance for the LAPAROSCOPIC SURGICAL INSTRUMENT. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Gabris Surgical Corp. (Virginia Beach, US). The FDA issued a Cleared decision on September 19, 1995 after a review of 53 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gabris Surgical Corp. devices

FDA 510(k) Submission Details - K953548

510(k) Number K953548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1995
Decision Date September 19, 1995
Days to Decision 53 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
107d faster than avg
Panel avg: 160d · This submission: 53d
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 226
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K953548.
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