Cleared Traditional

K040477 - MONODERM

K040477 is an FDA 510(k) clearance for MONODERM, manufactured by Surgical Specialties Corp. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K040477 · Surgical Specialties Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
84d
Days
Class 2
Risk

K040477 is an FDA 510(k) clearance for the MONODERM. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Surgical Specialties Corp (Reading, US). The FDA issued a Cleared decision on May 18, 2004 after a review of 84 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 Surgical Specialties Corp devices

FDA 510(k) Submission Details - K040477

510(k) Number K040477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2004
Decision Date May 18, 2004
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 86
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K040477.
POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
K042141 · Teleflex Medical · Sep 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K042233 · Depuy Mitek, A Johnson & Johnson Company · Sep 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K041806 · Depuy Mitek, A Johnson & Johnson Company · Aug 2004
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
K033746 · Ethicon, Inc. · Dec 2003
CAPROSYN ABSORBABLE SUTURE
K032586 · United States Surgical, A Division of Tyco Healthc · Nov 2003
ORTHODEK
K033115 · Teleflex Medical · Nov 2003