510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K891027Substantially Equivalent

Zsi Biopsy Forceps

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

K891027 is the FDA 510(k) clearance record for ZSI BIOPSY FORCEPS, a class I device, cleared for Zinnanti Surgical Instruments, Inc. on under FDA product code HFB (Forceps, Biopsy, Gynecological). FDA records list 76 510(k) clearances for Zinnanti Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K891027.

Clearance record

Decision date
Received
(17 days to decision)
Product code
HFB Forceps, Biopsy, Gynecological
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Zinnanti Surgical Instruments, Inc. 21540-B Prairie St., Chatsworth CA
Third party review
No

Clearances, product code HFB

Trailing 12 months

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

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