510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926021Substantially Equivalent

Needle Holders & Access for Lapar Surg-Ob/gyn Use

Zinnanti Surgical Instruments, Inc., Chatsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926021 is the FDA 510(k) clearance record for NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE, a class II device, cleared for Zinnanti Surgical Instruments, Inc. on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 76 510(k) clearances for Zinnanti Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K926021.

Clearance record

Decision date
Received
(493 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Zinnanti Surgical Instruments, Inc. 21540-B Prairie St., Chatsworth CA
510(k) summary
Statement
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, 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