Cleared Traditional

K980209 - SIMPLICARE THIN FILM WOUND DRESSINGS (FDA 510(k) Clearance)

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

Submission Details

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
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 114d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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