Cleared Traditional

K980209 - SIMPLICARE THIN FILM WOUND DRESSINGS

K980209 · Hollister, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
31d
Days
-
Risk

K980209 is an FDA 510(k) clearance for the SIMPLICARE THIN FILM WOUND DRESSINGS. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on February 20, 1998 after a review of 31 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 - K980209

510(k) Number K980209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 20, 1998
Decision Date February 20, 1998
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 12
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K980209.
SIMPLICARE TRANSPARENT WOUND DRESSING
K991214 · Hollister, Inc. · Oct 1999
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0
K981713 · Smith & Nephew, Inc. · Jul 1998
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
ULTEC THIN HYDROCOLLOID DRESSING
K952071 · Sherwood Medical Co. · Jun 1995
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
K950065 · Conmedcorp · Mar 1995
CUTIPLAST STERIL
K943363 · Beiersdorf, Inc. · Mar 1995