Cleared Traditional

K002328 - SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR

K002328 is an FDA 510(k) clearance for SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K002328 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
391d
Days
Class 2
Risk

K002328 is an FDA 510(k) clearance for the SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SI.... Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on August 27, 2001 after a review of 391 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K002328

510(k) Number K002328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2000
Decision Date August 27, 2001
Days to Decision 391 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
231d slower than avg
Panel avg: 160d · This submission: 391d
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 K002328.
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · Northgate Technologies, Inc. · Jan 2003
UHI-3 HIGH FLOW INSUFFLATION UNIT
K014166 · Olympus Optical Co., Ltd. · Jun 2002
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · Northgate Technologies, Inc. · Oct 2001
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
K000180 · Richard Wolf Medical Instruments Corp. · Mar 2001
TAUT-INSUFFLATION NEEDLE
K003703 · Taut, Inc. · Feb 2001
STRYKER HEATED INSUFFLATOR TUBE SET
K003792 · Stryker Corp. · Feb 2001