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
K091240Substantially Equivalent

Alphamed Surgical Spear, Model 70-5000

Alphamed, Inc., El Paso TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K091240 is the FDA 510(k) clearance record for ALPHAMED SURGICAL SPEAR, MODEL 70-5000, a class II device, cleared for Alphamed, Inc. on under FDA product code HOZ (Sponge, Ophthalmic). FDA records list 4 510(k) clearances for Alphamed, Inc., from to . As of , FDA records show no recalls naming K091240.

Clearance record

Decision date
Received
(179 days to decision)
Product code
HOZ Sponge, Ophthalmic
Regulation
21 CFR 886.4790
Device class
Class II
Review panel
Ophthalmic
Applicant
Alphamed, Inc. 3912 Mountain Ave., El Paso TX
510(k) summary
Statement
Third party review
No

Clearances, product code HOZ

Trailing 12 months

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

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