Cleared Traditional

K081173 - ENDOSCOPIC CO2 REGULATION UNIT UCR

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

K081173 · Olympus Medical Systems Corporation · Obstetrics & Gynecology device
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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.

View all Olympus Medical Systems Corporation devices

Submission Details

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
83d slower than avg
Panel avg: 160d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 145
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K081173.
OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
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K080948 · Olympus Medical Systems Corporation · Sep 2008
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K062097 · PAJUNK GmbH Medizintechnologie · Oct 2006