Cleared Traditional

K081173 - ENDOSCOPIC CO2 REGULATION UNIT UCR

K081173 is an FDA 510(k) clearance for ENDOSCOPIC CO2 REGULATION UNIT UCR, manufactured by Olympus Medical Systems Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K081173 · Olympus Medical Systems Corporation · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
243d
Days
Class 2
Risk

K081173 is an FDA 510(k) clearance for the ENDOSCOPIC CO2 REGULATION UNIT UCR. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on December 23, 2008 after a review of 243 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K081173

510(k) Number K081173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2008
Decision Date December 23, 2008
Days to Decision 243 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
82d slower than avg
Panel avg: 161d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K081173.
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STRYKER VIDEOSCOPE
K082451 · Stryker Endoscopy · Dec 2008
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
K080948 · Olympus Medical Systems Corporation · Sep 2008
VERESS CANNULA AND MODULAR VERESS CANNULA
K062097 · PAJUNK GmbH Medizintechnologie · Oct 2006
K081173 · ENDOSCOPIC CO2 REGULATION UNIT UCR
Download PDF FDA Summary Olympus Medical Syste…