Cleared Traditional

K033762 - SERRALAPG

K033762 is an FDA 510(k) clearance for SERRALAPG, manufactured by Serral, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K033762 · Serral, S.A. DE C.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
104d
Days
Class 2
Risk

K033762 is an FDA 510(k) clearance for the SERRALAPG. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on March 15, 2004 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Serral, S.A. DE C.V. devices

FDA 510(k) Submission Details - K033762

510(k) Number K033762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2003
Decision Date March 15, 2004
Days to Decision 104 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 115d · This submission: 104d
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 110
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K033762.
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
MONODERM
K040477 · Surgical Specialties Corp · May 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