Cleared Traditional

K983394 - MODIFICATION TO TIELLE HYDROPOLMER DRESSING

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

FDA 510(k) Submission Details - K983394

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
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 57
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K983394.
MEPITEL NON ADHERENT SILICONE DRESSING
K984371 · Molnlycke Health Care, Inc. · Mar 1999
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS
K983303 · Innovative Technologies , Ltd. · Dec 1998
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
K983234 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Nov 1998
MEPILEX
K983184 · Molnlycke Health Care, Inc. · Oct 1998
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013
K974891 · Acutek Adhesive Specialties, Inc. · Oct 1998
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
K974890 · Acutek Adhesive Specialties, Inc. · Oct 1998