510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944444Substantially Equivalent

Cit Biopsy Punches

Chirurgische Instrumente, Balgheim, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944444 is the FDA 510(k) clearance record for CIT BIOPSY PUNCHES, a class I device, cleared for Chirurgische Instrumente on under FDA product code HFB (Forceps, Biopsy, Gynecological). FDA records list 4 510(k) clearances for Chirurgische Instrumente, from to . As of , FDA records show no recalls naming K944444.

Clearance record

Decision date
Received
(413 days to decision)
Product code
HFB Forceps, Biopsy, Gynecological
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Chirurgische Instrumente Hauptstrabe 18, Balgheim, DE
510(k) summary
Statement
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