Cleared Traditional

K071708 - I45

K071708 is an FDA 510(k) clearance for I45, manufactured by Power Medical Interventions, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K071708 · Power Medical Interventions, Inc. · General & Plastic Surgery device
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Sep 2007
Decision
98d
Days
Class 2
Risk

K071708 is an FDA 510(k) clearance for the I45, I45S, I60, AND I60S. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Power Medical Interventions, Inc. (Langhorne, US). The FDA issued a Cleared decision on September 27, 2007 after a review of 98 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 Power Medical Interventions, Inc. devices

FDA 510(k) Submission Details - K071708

510(k) Number K071708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2007
Decision Date September 27, 2007
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
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 169
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K071708.
IDRIVES, IDRIVEC, IDRIVEF
K073001 · Power Medical Interventions, Inc. · Dec 2007
IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
K073148 · Power Medical Interventions, Inc. · Dec 2007
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · United States Surgical, A Division of Tyco Healthc · Sep 2007
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
K070887 · Ethicon Endo-Surgery, LLC · May 2007
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
K062869 · Ethicon Endo-Surgery, LLC · Feb 2007
POWER EXTENDERS MODEL# PEC200, PES200,PES200S
K063746 · Power Medical Interventions, Inc. · Jan 2007