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

FDA 510(k) Submission Details - K955506

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

68d faster than avg

Panel avg: 115d · This submission: 47d

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 124

Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K955506.

SIS WOUND DRESSING

K973170 · Cook Biotech, Inc. · Apr 1998

KENDALL HYDROPHILIC POWDER WOUND DRESSING

K970266 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1997

REPLIDERM WOUND DRESSING

K963228 · Orphan Medical, Inc. · Dec 1996

MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING

K950032 · Brennen Medical, Inc. · Jun 1995

MESH MATRIX WOUND DRESSING

K950281 · Brennen Medical, Inc. · Apr 1995

E-Z DERM BIOSYNTHETIC WOUND DRESSING

K935189 · Brennen Medical, Inc. · Jul 1994

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K955506

The Hymed Group Corp.

Bethlehem, PA · US

GEORGE D PETITO

Regulatory profile

6 submissions 4 cleared

67% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 17, 1996. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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