Cleared Traditional

K994339 - HYCURE ORAL / HYCURE ORAL SMART GEL

K994339 · The Hymed Group Corp. · General & Plastic Surgery device
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Mar 2000
Decision
90d
Days
-
Risk

K994339 is an FDA 510(k) clearance for the HYCURE ORAL / HYCURE ORAL SMART GEL. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by The Hymed Group Corp. (Bethlehem, US). The FDA issued a Cleared decision on March 22, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K994339

510(k) Number K994339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date March 22, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 189
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K994339.
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
K003134 · Adri/Technam · Dec 2000
COLLAGEN WOUND DRESSING
K002443 · Oasis Research, LLC · Oct 2000
MEDTRADE PRODUCTS ALGINATE ISLAND
K000487 · Medtrade Products , Ltd. · Apr 2000
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
K000054 · Adri · Mar 2000
SIS WOUND DRESSING II
K993948 · Cook Biotech, Inc. · Jan 2000
SIGNADRESS DUODERM DRESSING
K990964 · Convatec, A Division of E.R. Squibb & Sons · May 1999
K994339 · HYCURE ORAL / HYCURE ORAL SMART GEL
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