510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K910254Unknown

Diagnostic Hysteroscopy Redikit (Tm)

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

K910254 is the FDA 510(k) clearance record for DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM), a class II device, cleared for CooperSurgical, Inc. on under FDA product code HHE (Cup, Menstrual). FDA's definition for product code HHE reads: "A menstrual cup is a receptacle placed in the vagina to collect menstrual flow". FDA records list 103 510(k) clearances for CooperSurgical, Inc., from to . As of , FDA records show no recalls naming K910254.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HHE Cup, Menstrual
Regulation
21 CFR 884.5400
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 HHE

Trailing 12 months

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

FDA records show no clearances under product code HHE in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HHE, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260