510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000180Substantially Equivalent

Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set, Instrument Set for the Transanal Endoscop

Richard Wolf Medical Instruments Corp., Vernon Hills IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000180 is the FDA 510(k) clearance record for TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP, a class II device, cleared for Richard Wolf Medical Instruments Corp. on under FDA product code HIF (Insufflator, Laparoscopic). FDA records list 153 510(k) clearances for Richard Wolf Medical Instruments Corp., from to . As of , FDA records show 3 recalls naming K000180.

Clearance record

Decision date
Received
(407 days to decision)
Product code
HIF Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Richard Wolf Medical Instruments Corp. 353 Corporate Woods Pkwy., Vernon Hills IL
510(k) summary
Summary
Third party review
No

Clearances, product code HIF

Trailing 12 months
3 clearances under product code HIF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260