Cleared Traditional

K926259 - SURGIMAT

K926259 is an FDA 510(k) clearance for SURGIMAT, manufactured by W.O.M. World of Medicine GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 635-day FDA review.

K926259 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology device
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Sep 1994
Decision
635d
Days
Class 2
Risk

K926259 is an FDA 510(k) clearance for the SURGIMAT. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by W.O.M. World of Medicine GmbH (Tucson, US). The FDA issued a Cleared decision on September 14, 1994 after a review of 635 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 W.O.M. World of Medicine GmbH devices

FDA 510(k) Submission Details - K926259

510(k) Number K926259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1992
Decision Date September 14, 1994
Days to Decision 635 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
475d slower than avg
Panel avg: 160d · This submission: 635d
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 225
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K926259.
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ZEISS OPMI L STEREO-LAPAROSCOPE
K931478 · Carl Zeiss, Inc. · Sep 1994
SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
K936071 · Smith & Nephew Dyonics, Inc. · Aug 1994
VIDEO ENDOSCOPE-RIGID MODIFICATION
K921294 · Medical Dynamics, Inc. · Jul 1994
IRRIGATION PUMP AND TUBING SET
K924611 · Marlo Surgical Technology · Jun 1994