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Hemamyst Surgical Applicator System, Model H-AS01

by Haemacure Corp.

510(k) K041504

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041504 Date6 Aug 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Hemamyst Surgical Applicator System, Model H-AS01 is a sterile, single-use device designed for the simultaneous spray delivery of two-component fibrin sealants, specifically HEMASEEL APR or Tisseel VH, to surgical sites. It is indicated for the application of these sealants to the treatment site during surgical procedures.

The device is supplied in a sterile condition and is intended for single-use only. It has received FDA 510(k) clearance under K041504 with product code FMF and was determined to be substantially equivalent to a predicate device. The system is used in general hospital settings for surgical applications involving fibrin sealant delivery.

Other devices from Haemacure Corp.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Hemamyst Surgical Applicator System Model H-AS01 used for?

    It is designed for the simultaneous spray delivery of two-component fibrin sealants, specifically HEMASEEL APR or Tisseel VH, to surgical sites during procedures. This allows for controlled application of sealants to promote hemostasis and tissue bonding in general hospital surgical settings.

  • Is the Hemamyst Surgical Applicator System Model H-AS01 sterile and single-use?

    Yes, the device is supplied in a sterile condition and is intended for single-use only. This ensures infection control and eliminates the need for reprocessing, making it suitable for immediate use in surgical environments where sterility is critical.

  • What regulatory clearance does the Hemamyst Surgical Applicator System Model H-AS01 have?

    The device has received FDA 510(k) clearance under submission number K041504, with product code FMF. It was determined to be substantially equivalent to a predicate device through a traditional review process, as indicated in the authorization data.