Cleared Traditional

K994023 - HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01

K994023 is an FDA 510(k) clearance for HAEMACURE HEMAMYST SURGICAL APPLICATOR ..., manufactured by Haemacure Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K994023 · Haemacure Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K994023

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
Combination Product No
PCCP Authorized No
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.

FMF Device Classification - Class 2, Special Controls

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 387
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K994023.
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000
TERUMO U-100 INSULIN SYRING
K001474 · Terumo Medical Corp. · Jun 2000
THE WAND
K992404 · Spintech, Inc. · Jun 2000
ULTICARE DISPOSABLE SYRINGE
K994230 · Ultimed, Inc. · Mar 2000
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
K993017 · Shinchang Medical Co., Ltd. · Feb 2000
VEIN ENTRY INDICATOR DEVICE (VEID)
K993995 · Vascular Technologies , Ltd. · Feb 2000