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
K902119Substantially Equivalent

Safebris Sterile Circumcision Kit

Kedumin Kits, Ltd., Rehovot, Israel, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902119 is the FDA 510(k) clearance record for SAFEBRIS STERILE CIRCUMCISION KIT, a class II device, cleared for Kedumin Kits, Ltd. on under FDA product code FHJ (Shield, Circumcision). FDA records list one 510(k) clearance for Kedumin Kits, Ltd. As of , FDA records show no recalls naming K902119.

Clearance record

Decision date
Received
(180 days to decision)
Product code
FHJ Shield, Circumcision
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Kedumin Kits, Ltd. P.O. Box 2273, Rehovot, Israel, IL
Third party review
No

Clearances, product code FHJ

Trailing 12 months

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

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