Cleared Traditional

SURGIFLATOR 20 (K950035) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

Device Classification

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 176
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K950035.
Insufflator (OPTO-IFL1000)
K252318 · Guangdong Optomedic Technologies, Inc. · Apr 2026
ENDOFLATOR +
K250388 · Karl Storz SE & CO. KG · Sep 2025
AirSurgN Insufflator (10030/AirSurgN)
K242772 · Smartsurgn, Inc. · Apr 2025
High Flow Insufflation Unit (UHI-4)
K243527 · Olympus Medical Systems Corporation · Jan 2025
TauTona Pneumoperitoneum Assist Device (TPAD)
K242536 · Tautona Group · Oct 2024
VereSee Optical Veres Needle System
K232464 · Freyja Healthcare, LLC · May 2024