Skip to content

Sorbastace

by Hemostace, LLC

510(k) K965034

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

Overview

At Hemostace, LLC, we've developed the SORBASTACE wound dressing, a groundbreaking traditional hemostatic dressing without thrombin or other biologics. This innovative device provides rapid and effective control of bleeding in acute wounds, making it an essential tool for medical professionals and patients alike.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK965034 Date9 Apr 1998DecidedStatusActive

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  • Withdrawn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
QSY
Device Class
U
Advisory Committee
Unknown
FDA Decision
SN