510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K081173Substantially Equivalent

Endoscopic CO2 Regulation Unit Ucr

Olympus Medical Systems Corp., Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081173 is the FDA 510(k) clearance record for ENDOSCOPIC CO2 REGULATION UNIT UCR, a class II device, cleared for Olympus Medical Systems Corporation on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 186 510(k) clearances for Olympus Medical Systems Corporation, from to . As of , FDA records show no recalls naming K081173.

Clearance record

Decision date
Received
(243 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Olympus Medical Systems Corporation 3500 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HET

Trailing 12 months

FDA records hold no clearances under product code HET in the trailing twelve months.

FDA records show no clearances under product code HET in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260