Cleared Traditional

K983394 - MODIFICATION TO TIELLE HYDROPOLMER DRES...

K983394 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
39d
Days
-
Risk

K983394 is an FDA 510(k) clearance for the MODIFICATION TO TIELLE HYDROPOLMER DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Johnson & Johnson Medical, Div. of Ethicon, Inc. (Arlington, US). The FDA issued a Cleared decision on November 3, 1998 after a review of 39 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 Johnson & Johnson Medical, Div. of Ethicon, Inc. devices

Submission Details

510(k) Number K983394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1998
Decision Date November 03, 1998
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 13
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K983394.
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
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · Hollister, Inc. · Feb 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