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.

View all The Hymed Group Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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

All 76
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K994339.
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ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
MEDLINE COLLAGEN WOUND DRESSING
K060456 · Medline Industries, Inc. · Jun 2006
SIGNADRESS DUODERM DRESSING
K990964 · Convatec, A Division of E.R. Squibb & Sons · May 1999
HA ABSORBENT WOUND DRESSING
K984388 · Convatec, A Division of E.R. Squibb & Sons · Mar 1999