Cleared Traditional

K955506 - HYCURE

K955506 · The Hymed Group Corp. · General & Plastic Surgery device
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Jan 1996
Decision
47d
Days
-
Risk

K955506 is an FDA 510(k) clearance for the HYCURE. 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 January 17, 1996 after a review of 47 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Hymed Group Corp. devices

Submission Details

510(k) Number K955506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date January 17, 1996
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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