Cleared Traditional

K954621 - RECLOSABLE WOUND COVER

K954621 · Hollister, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
18d
Days
-
Risk

K954621 is an FDA 510(k) clearance for the RECLOSABLE WOUND COVER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on October 23, 1995 after a review of 18 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K954621

510(k) Number K954621 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 05, 1995
Decision Date October 23, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 227
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K954621.
KENDALL CURITY PETROLATUM GAUZE
K973511 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
K973507 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
SIGNALDRESS
K962590 · Convatec, A Division of E.R. Squibb & Sons · Sep 1996
HOLLISTER HYDROCOLLOID WOUND DRESSING
K954235 · Hollister, Inc. · Oct 1995
SALINE DRESSING
K952948 · Busse Hospital Disposables, Inc. · Aug 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995