Cleared Traditional

K093845 - ETHICON SECURESTRAP 5MM ABSORBABLE STRA...

K093845 is the FDA 510(k) clearance for ETHICON SECURESTRAP 5MM ABSORBABLE STRA... by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K093845 · Ethicon, Inc. · General & Plastic Surgery device
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Apr 2010
Decision
113d
Days
Class 2
Risk

K093845 is an FDA 510(k) clearance for the ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on April 7, 2010 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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 Ethicon, Inc. devices

Submission Details

510(k) Number K093845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2009
Decision Date April 07, 2010
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 156
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K093845.
REUSABLE LINEAR STAPLER HANDLE
K110049 · Ethicon Endo-Surgery, LLC · Feb 2011
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
K102632 · Ethicon Endo-Surgery, Inc. · Oct 2010
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K102291 · Covidien · Sep 2010
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
K092483 · C.R. Bard, Inc. · Dec 2009
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
K092577 · Ethicon Endo-Surgery, LLC · Sep 2009
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
K091322 · Ethicon Endo-Surgery, Inc. · Jun 2009