510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994023Substantially Equivalent

Haemacure Hemamyst Surgical Applicator System H-As01

Haemacure Corp., Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994023 is the FDA 510(k) clearance record for HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01, a class II device, cleared for Haemacure Corp. on under FDA product code FMF (Syringe, Piston). FDA records list 2 510(k) clearances for Haemacure Corp., from to . As of , FDA records show no recalls naming K994023.

Clearance record

Decision date
Received
(151 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Haemacure Corp. 2 N. Tamiami Trl., #802, Sarasota FL
510(k) summary
Summary
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260