510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K964276Substantially Equivalent

Endoscopic Hysterectomy and Uterus Manipulator

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

K964276 is the FDA 510(k) clearance record for ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR, a class II device, cleared for Richard Wolf Medical Instruments Corp. on under FDA product code HEW (Culdoscope (And Accessories)). FDA records list 153 510(k) clearances for Richard Wolf Medical Instruments Corp., from to . As of , FDA records show no recalls naming K964276.

Clearance record

Decision date
Received
(393 days to decision)
Product code
HEW Culdoscope (And Accessories)
Regulation
21 CFR 884.1640
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 HEW

Trailing 12 months

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

FDA records show no clearances under product code HEW in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEW, 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