Cleared Traditional

K950933 - HOLLISTER HYDROCOLLOID WOUND DRESSINGS

K950933 · Hollister, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
132d
Days
-
Risk

K950933 is an FDA 510(k) clearance for the HOLLISTER HYDROCOLLOID WOUND DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hollister, Inc. devices

FDA 510(k) Submission Details - K950933

510(k) Number K950933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1995
Decision Date July 11, 1995
Days to Decision 132 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 115d · This submission: 132d
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 K950933.
RECLOSABLE WOUND COVER
K954621 · Hollister, Inc. · Oct 1995
HOLLISTER HYDROCOLLOID WOUND DRESSING
K954235 · Hollister, Inc. · Oct 1995
SALINE DRESSING
K952948 · Busse Hospital Disposables, Inc. · Aug 1995
PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995
SALINE WET DRESSING- STERILE
K934258 · Trinity Laboratories, Inc. · Nov 1993
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991