510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910253Substantially Equivalent

Leep Redikit

CooperSurgical, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910253 is the FDA 510(k) clearance record for LEEP REDIKIT, a class II device, cleared for CooperSurgical, Inc. on under FDA product code HEE (Set, Anesthesia, Paracervical). FDA records list 103 510(k) clearances for CooperSurgical, Inc., from to . As of , FDA records show 2 recalls naming K910253.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HEE Set, Anesthesia, Paracervical
Regulation
21 CFR 884.5100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
CooperSurgical, Inc. C/O Charles I. Rose & Co, Inc., Mountain View CA
Third party review
No

Clearances, product code HEE

Trailing 12 months

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

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