Cleared Traditional

HERCON ANTI. TRANS. DRESSING AS A WOUND DRESSING (K870743) - FDA 510(k) Clearance

K870743 · Hercon Laboratories Corp. · General & Plastic Surgery device
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Apr 1987
Decision
55d
Days
-
Risk

K870743 is an FDA 510(k) clearance for the HERCON ANTI. TRANS. DRESSING AS A WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hercon Laboratories Corp. (So. Plainfield, US). The FDA issued a Cleared decision on April 6, 1987 after a review of 55 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 Hercon Laboratories Corp. devices

Submission Details

510(k) Number K870743 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 10, 1987
Decision Date April 06, 1987
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K870743.
TEGASORB ULCER DRESSING #90-XXX
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K881048 · Smith & Nephew, Inc. · Mar 1988
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
VISCOPASTE ZINC PASTE BANDAGE
K863930 · Smith & Nephew, Inc. · Dec 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163 · Johnson & Johnson Professionals, Inc. · Jul 1986
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384 · Johnson & Johnson Professionals, Inc. · Jul 1986