Cleared Traditional

FERRIS DYNADERM PLUS (K865089) - FDA 510(k) Clearance

K865089 · Ferris Mfg. Corp. · General & Plastic Surgery device
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Feb 1987
Decision
36d
Days
-
Risk

K865089 is an FDA 510(k) clearance for the FERRIS DYNADERM PLUS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 36 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 Ferris Mfg. Corp. devices

Submission Details

510(k) Number K865089 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 30, 1986
Decision Date February 04, 1987
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 163
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K865089.
TEGASORB ULCER DRESSING #90-XXX
K872298 · 3M Company · Apr 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
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