510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874367Substantially Equivalent

Various Cardiac Cryoprobes Having Dia. & Cos. Diff

Spembly Medical, Ltd., England, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874367 is the FDA 510(k) clearance record for VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF, a class II device, cleared for Spembly Medical , Ltd. on under FDA product code HQO (Unit, Cautery, Thermal, Ac-Powered). FDA records list 17 510(k) clearances for Spembly Medical , Ltd., from to . As of , FDA records show no recalls naming K874367.

Clearance record

Decision date
Received
(73 days to decision)
Product code
HQO Unit, Cautery, Thermal, Ac-Powered
Regulation
21 CFR 886.4115
Device class
Class II
Review panel
Ophthalmic
Applicant
Spembly Medical , Ltd. Newbury Rd., England, GB
Third party review
No

Clearances, product code HQO

Trailing 12 months

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

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