Cleared Traditional

K102325 - IDRIVE SYSTEM (I DRIVE POWER HANDLE

K102325 is the FDA 510(k) clearance for IDRIVE SYSTEM (I DRIVE POWER HANDLE by Covidien, LLC, Formerly Registered AS Tyco Healthca. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K102325 · Covidien, LLC, Formerly Registered AS Tyco Healthca · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
57d
Days
Class 2
Risk

K102325 is an FDA 510(k) clearance for the IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD). Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien, LLC, Formerly Registered AS Tyco Healthca (North Haven, US). The FDA issued a Cleared decision on October 13, 2010 after a review of 57 days - a notably fast clearance cycle.

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: 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 Covidien, LLC, Formerly Registered AS Tyco Healthca devices

Submission Details

510(k) Number K102325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2010
Decision Date October 13, 2010
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 158
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K102325.
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
K103672 · Ethicon Endo-Surgery, LLC · Apr 2011
ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
K110385 · Ethicon Endo-Surgery, Inc. · Mar 2011
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
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
K093845 · Ethicon, Inc. · Apr 2010