510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944055Substantially Equivalent

Forceps, Surgical Gynecological

Owens Precision Systems, Inc., Oak Creek WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944055 is the FDA 510(k) clearance record for FORCEPS, SURGICAL GYNECOLOGICAL, a class II device, cleared for Owens Precision Systems, Inc. on under FDA product code HCZ (Forceps, Surgical, Gynecological). FDA records list 3 510(k) clearances for Owens Precision Systems, Inc., from to . As of , FDA records show no recalls naming K944055.

Clearance record

Decision date
Received
(32 days to decision)
Product code
HCZ Forceps, Surgical, Gynecological
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Owens Precision Systems, Inc. 7815 S. 6th St., Oak Creek WI
510(k) summary
Summary
Third party review
No

Clearances, product code HCZ

Trailing 12 months

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

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