Cleared Traditional

K990372 - MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY

K990372 is an FDA 510(k) clearance for MODULAR INSTRUMENT SYSTEM FOR MINIMAL I..., manufactured by Dr. Fritz GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K990372 · Dr. Fritz GmbH · Obstetrics & Gynecology device
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Oct 1999
Decision
248d
Days
Class 2
Risk

K990372 is an FDA 510(k) clearance for the MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Dr. Fritz GmbH (Baldwin Park, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 248 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Dr. Fritz GmbH devices

FDA 510(k) Submission Details - K990372

510(k) Number K990372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date October 14, 1999
Days to Decision 248 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 160d · This submission: 248d
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 215
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K990372.
CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
K992481 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Mar 2000
THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
K992513 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Mar 2000
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801 · Ethicon, Inc. · Feb 2000
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
K992480 · Medifix, Inc. · Sep 1999
LAP-WAVE 3000 (P07)
K990732 · W.O.M. World of Medicine GmbH · Jul 1999
DCI ENDOSCOPE
K990004 · KARL STORZ Endoscopy-America, Inc. · Apr 1999