Cleared Special

K073001 - IDRIVES

K073001 is an FDA 510(k) clearance for IDRIVES, manufactured by Power Medical Interventions, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 55-day FDA review.

K073001 · Power Medical Interventions, Inc. · General & Plastic Surgery device
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Dec 2007
Decision
55d
Days
Class 2
Risk

K073001 is an FDA 510(k) clearance for the IDRIVES, IDRIVEC, IDRIVEF. 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 December 18, 2007 after a review of 55 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Power Medical Interventions, Inc. devices

FDA 510(k) Submission Details - K073001

510(k) Number K073001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2007
Decision Date December 18, 2007
Days to Decision 55 days
Submission Type Special
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
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

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 K073001.
INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
K081826 · Power Medical Interventions, Inc. · Jul 2008
ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)
K081146 · Ethicon Endo-Surgery, LLC · Jun 2008
ECHELON GRAY CARTRIDGE, MODEL ERC45M
K080839 · Ethicon Endo-Surgery, LLC · May 2008
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
I45, I45S, I60, AND I60S
K071708 · Power Medical Interventions, Inc. · Sep 2007