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
K943932Substantially Equivalent

Steriseal Ophthalmic Cannula

Pharma-Plast, Ltd., Redditch, Worcestershire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943932 is the FDA 510(k) clearance record for STERISEAL OPHTHALMIC CANNULA, a class I device, cleared for Pharma-Plast, Ltd. on under FDA product code HMX (Cannula, Ophthalmic). FDA records list one 510(k) clearance for Pharma-Plast, Ltd. As of , FDA records show no recalls naming K943932.

Clearance record

Decision date
Received
(159 days to decision)
Product code
HMX Cannula, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Pharma-Plast, Ltd. Steriseal Division, Redditch, Worcestershire, GB
510(k) summary
Statement
Third party review
No

Clearances, product code HMX

Trailing 12 months

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

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