Cleared Traditional

K093845 - ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25

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

K093845 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K093845

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.

GDW Device Classification - Class 2, Special Controls

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 281
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K093845.
FRANKENMAN SURGICAL STAPLERS
K101378 · Suzhou Frankenman Medical Equipment Co., Ltd. · Jun 2010
AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
K101444 · Surgical Devices, A Global Business Unit Tyco · Jun 2010
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5
K100723 · Changzhou Kangdi Medical Stapler Co., Ltd. · Apr 2010
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
K100386 · Changzhou Waston Medical Appliance Co., Ltd. · Mar 2010
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
K092483 · C.R. Bard, Inc. · Dec 2009
AMID STAPLER
K093253 · Safestitch, LLC · Nov 2009
K093845 · ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
Download PDF FDA Summary Ethicon, Inc.