Cleared Traditional

K926259 - SURGIMAT

K926259 is the FDA 510(k) clearance for SURGIMAT by W.O.M. World of Medicine GmbH. It is a Class 2 Obstetrics & Gynecology device (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 151
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K926259.
LAPAROVIEW
K931065 · Northgate Technologies, Inc. · Nov 1994
INSUFFLATOR TUBING WITH FILTER
K943508 · Stryker Endoscopy · Nov 1994
ZEISS OPMI L STEREO-LAPAROSCOPE
K931478 · Carl Zeiss, Inc. · Sep 1994
ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)
K940505 · Uresil Corp. · Jun 1994
DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE
K941334 · Davol, Inc. · Jun 1994
SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS
K940709 · Baxter Healthcare Corp · May 1994