Cleared Special

K040024 - SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29

K040024 is an FDA 510(k) clearance for SURGASSIST CIRCULAR STAPLER DIGITAL LOA..., 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 28-day FDA review.

K040024 · Power Medical Interventions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
28d
Days
Class 2
Risk

K040024 is an FDA 510(k) clearance for the SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Power Medical Interventions, Inc. (New Hope, US). The FDA issued a Cleared decision on February 4, 2004 after a review of 28 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 - K040024

510(k) Number K040024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2004
Decision Date February 04, 2004
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 270
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K040024.
SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM
K040720 · Power Medical Interventions, Inc. · Jun 2004
ULTRACLIP II MR
K041201 · Inrad · Jun 2004
SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS
K040398 · Power Medical Interventions, Inc. · Mar 2004
CURVED CUTTER STAPLER, MODELS CS40B, CS40G
K040038 · Ethicon Endo-Surgery, Inc. · Feb 2004
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
K032973 · Vanguard Medical Concepts, Inc. · Dec 2003
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
K032696 · United States Surgical, A Division of Tyco Healthc · Dec 2003