510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974313Substantially Equivalent

Hydrofera Surgical Spear

Hydrofera, LLC., Willimantic CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974313 is the FDA 510(k) clearance record for HYDROFERA SURGICAL SPEAR, a class II device, cleared for Hydrofera, LLC on under FDA product code HOZ (Sponge, Ophthalmic). FDA records list 7 510(k) clearances for Hydrofera, LLC, from to . As of , FDA records show no recalls naming K974313.

Clearance record

Decision date
Received
(105 days to decision)
Product code
HOZ Sponge, Ophthalmic
Regulation
21 CFR 886.4790
Device class
Class II
Review panel
Ophthalmic
Applicant
Hydrofera, LLC 322 Main St., Suite 1101, Willimantic CT
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