Cleared Traditional

HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01 (K994023) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994023 · Haemacure Corp. · General Hospital
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Apr 2000
Decision
151d
Days
Class 2
Risk

K994023 is an FDA 510(k) clearance for the HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Haemacure Corp. (Sarasota, US). The FDA issued a Cleared decision on April 25, 2000 after a review of 151 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Haemacure Corp. devices

Submission Details

510(k) Number K994023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date April 25, 2000
Days to Decision 151 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 129d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 209
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K994023.
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories · Jan 2001
DUPLOGRIP
K003193 · Baxter Healthcare Corp · Nov 2000
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000
VACLOK SYRINGE
K994253 · Merit Medical Systems, Inc. · Jan 2000
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
BECTON DICKINSON SYRINGES
K980580 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998