Cleared Traditional

K040720 - SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM

K040720 is an FDA 510(k) clearance for SURGASSIST COMPUTER MEDIATED LINEAR CUT..., 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 76-day FDA review.

K040720 · Power Medical Interventions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
76d
Days
Class 2
Risk

K040720 is an FDA 510(k) clearance for the SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 M.... 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 June 3, 2004 after a review of 76 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 Power Medical Interventions, Inc. devices

FDA 510(k) Submission Details - K040720

510(k) Number K040720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2004
Decision Date June 03, 2004
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
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 270
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K040720.
HAND STC, MODEL 60MM
K042492 · Niti Medical Technologies , Ltd. · Oct 2004
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BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
K041331 · Biopsy Sciences, LLC · 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
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29
K040024 · Power Medical Interventions, Inc. · Feb 2004