Cleared Traditional

K933768 - COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933768 · Mahe-Medizintechnik · Obstetrics & Gynecology device
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Jun 1994
Decision
333d
Days
Class 2
Risk

K933768 is an FDA 510(k) clearance for the COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Mahe-Medizintechnik (Nashville, US). The FDA issued a Cleared decision on June 27, 1994 after a review of 333 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 Mahe-Medizintechnik devices

Submission Details

510(k) Number K933768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date June 27, 1994
Days to Decision 333 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
173d slower than avg
Panel avg: 160d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 337
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