510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903303Substantially Equivalent

Spembly Medical 242 Cryounit/series 242 Cryoprobes

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

K903303 is the FDA 510(k) clearance record for SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES, a class II device, cleared for Spembly Medical , Ltd. on under FDA product code HPS (Unit, Cryophthalmic). FDA records list 17 510(k) clearances for Spembly Medical , Ltd., from to . As of , FDA records show no recalls naming K903303.

Clearance record

Decision date
Received
(79 days to decision)
Product code
HPS Unit, Cryophthalmic
Regulation
21 CFR 886.4170
Device class
Class II
Review panel
Ophthalmic
Applicant
Spembly Medical , Ltd. Newbury Rd., England, GB
Third party review
No

Clearances, product code HPS

Trailing 12 months

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

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