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
K931449Substantially Equivalent

Msp Ophthalmic (Eye Spud)

Medical Sterile Products, Inc., Rincon PR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931449 is the FDA 510(k) clearance record for MSP OPHTHALMIC (EYE SPUD), a class I device, cleared for Medical Sterile Products, Inc. on under FDA product code HNA (Spud, Ophthalmic). FDA records list 2 510(k) clearances for Medical Sterile Products, Inc., from to . As of , FDA records show no recalls naming K931449.

Clearance record

Decision date
Received
(161 days to decision)
Product code
HNA Spud, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Medical Sterile Products, Inc. P.O. Box 338, Rincon PR
510(k) summary
Statement
Third party review
No

Clearances, product code HNA

Trailing 12 months

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

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