Cleared Traditional

K022318 - VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES

K022318 is an FDA 510(k) clearance for VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES, manufactured by Vomed Volzer Medizintechnik GmbH & Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K022318 · Vomed Volzer Medizintechnik GmbH & Co. · Obstetrics & Gynecology device
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Sep 2002
Decision
73d
Days
Class 2
Risk

K022318 is an FDA 510(k) clearance for the VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Vomed Volzer Medizintechnik GmbH & Co. (Amsterdam, Nh, NL). The FDA issued a Cleared decision on September 19, 2002 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vomed Volzer Medizintechnik GmbH & Co. devices

FDA 510(k) Submission Details - K022318

510(k) Number K022318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2002
Decision Date September 19, 2002
Days to Decision 73 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 faster than avg
Panel avg: 161d · This submission: 73d
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 154
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K022318.
LAPAROSHIELD CONDITIONED INSUFFLATION SET
K030469 · Pall Medical · May 2003
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · Northgate Technologies, Inc. · Jan 2003
PNEUMOPERITONEUM INSUFFLATION NEEDLE
K021247 · Mectra Labs, Inc. · Nov 2002
UHI-3 HIGH FLOW INSUFFLATION UNIT
K014166 · Olympus Optical Co., Ltd. · Jun 2002
MULTI HI-FLO PNEU, WISAP #7080
K011510 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Apr 2002
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · Northgate Technologies, Inc. · Oct 2001