Cleared Traditional

K000180 - TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP

K000180 is an FDA 510(k) clearance for TRANSANAL ENDOSCOPIC MICROSURGERY (TEM)..., 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 407-day FDA review.

K000180 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
407d
Days
Class 2
Risk

K000180 is an FDA 510(k) clearance for the TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET.... 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 March 2, 2001 after a review of 407 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K000180

510(k) Number K000180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2000
Decision Date March 02, 2001
Days to Decision 407 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
247d slower than avg
Panel avg: 160d · This submission: 407d
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 K000180.
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
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
K002328 · Richard Wolf Medical Instruments Corp. · Aug 2001
TAUT-INSUFFLATION NEEDLE
K003703 · Taut, Inc. · Feb 2001
STRYKER HEATED INSUFFLATOR TUBE SET
K003792 · Stryker Corp. · Feb 2001
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
K993625 · Genicon, LC · Jun 2000