Cleared Traditional

K950035 - SURGIFLATOR 20

K950035 is an FDA 510(k) clearance for SURGIFLATOR 20, manufactured by W.O.M. GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 404-day FDA review.

K950035 · W.O.M. GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
404d
Days
Class 2
Risk

K950035 is an FDA 510(k) clearance for the SURGIFLATOR 20. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by W.O.M. GmbH (Berlin, DE). The FDA issued a Cleared decision on February 12, 1996 after a review of 404 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - 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. GmbH devices

FDA 510(k) Submission Details - K950035

510(k) Number K950035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1995
Decision Date February 12, 1996
Days to Decision 404 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 160d · This submission: 404d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 - HIF Insufflator, Laparoscopic

All 124
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K950035.
SURGIFLATOR-20 PIM
K955791 · W.O.M. World of Medicine GmbH · Dec 1996
KSEA THERMOFLATOR (MODEL 26 4320 20)
K955073 · KARL STORZ Endoscopy-America, Inc. · Dec 1996
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
K962863 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
OLYMPUS HIGH FLOW INSUFFLATION UNIT
K953162 · Olympus America, Inc. · Dec 1995
ELECTRONIC LAPAROFLATOR
K951694 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
K951961 · KARL STORZ Endoscopy-America, Inc. · Aug 1995