Cleared Traditional

FERRIS HYDROPHILIC DRESSING (K880330) - FDA 510(k) Clearance

K880330 · Ferris Mfg. Corp. · General & Plastic Surgery device
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Mar 1988
Decision
56d
Days
-
Risk

K880330 is an FDA 510(k) clearance for the FERRIS HYDROPHILIC DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on March 23, 1988 after a review of 56 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 K880330 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 27, 1988
Decision Date March 23, 1988
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 K880330.
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · Baxter Healthcare Corp · Dec 1988
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