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
K974563Substantially Equivalent

Colpo Cup Cvc-2000

Clinical Innovations, LLC, Murray UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974563 is the FDA 510(k) clearance record for COLPO CUP CVC-2000, a class II device, cleared for Clinical Innovations, Inc. on under FDA product code HDP (Elevator, Uterine). FDA records list 18 510(k) clearances for Clinical Innovations, Inc., from to . As of , FDA records show no recalls naming K974563.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HDP Elevator, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Clinical Innovations, Inc. 6477 S. Cottonwood St., Murray UT
510(k) summary
Summary
Third party review
No

Clearances, product code HDP

Trailing 12 months

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

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