Cleared Traditional

TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (K983234) - FDA 510(k) Clearance

K983234 · 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
71d
Days
-
Risk

K983234 is an FDA 510(k) clearance for the TIELLE PLUS HYDROPOLYMER ADHESIVE 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 25, 1998 after a review of 71 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 K983234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1998
Decision Date November 25, 1998
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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