Cleared Traditional

K041806 - PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE (FDA 510(k) Clearance)

Also includes:

AND PASSING NEEDLE WITH ETHIBOND LOOP

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041806 · Depuy Mitek, A Johnson & Johnson Company · General & Plastic Surgery device

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Optimized for regulatory review, auditing and printing

Aug 2004

Decision

28d

Days

Class 2

Risk

K041806 is an FDA 510(k) clearance for the PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Norwood, US). The FDA issued a Cleared decision on August 3, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - the FDA general and plastic surgery device framework. 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 Depuy Mitek, A Johnson & Johnson Company devices

Submission Details

510(k) Number	K041806 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 06, 2004
Decision Date	August 03, 2004
Days to Decision	28 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

86d faster than avg

Panel avg: 114d · This submission: 28d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 878.4493

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.