510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K000227Substantially Equivalent

Umbicut

Pollak (Intl.).ltd, Rosh Ha'Ayin, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000227 is the FDA 510(k) clearance record for UMBICUT, a class II device, cleared for Pollak (Intl.), Ltd. on under FDA product code HFW (Clamp, Umbilical). FDA records list 31 510(k) clearances for Pollak (Intl.), Ltd., from to . As of , FDA records show no recalls naming K000227.

Clearance record

Decision date
Received
(94 days to decision)
Product code
HFW Clamp, Umbilical
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Pollak (Intl.), Ltd. Hamlacha 20, Industrial Zone, Rosh Ha'Ayin, IL
510(k) summary
Statement
Third party review
No

Clearances, product code HFW

Trailing 12 months

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

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