Cleared Traditional

K020719 - SURGASSIST SYSTEM STRAIGHT LINEAR CUTTE...

K020719 is an FDA 510(k) clearance for SURGASSIST SYSTEM STRAIGHT LINEAR CUTTE..., 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 66-day FDA review.

K020719 · Power Medical Interventions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
66d
Days
Class 2
Risk

K020719 is an FDA 510(k) clearance for the SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WIT.... 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 May 10, 2002 after a review of 66 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 - K020719

510(k) Number K020719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2002
Decision Date May 10, 2002
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
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 173
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K020719.
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K024275 · United States Surgical, A Division of Tyco Healthc · Mar 2003
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · United States Surgical, A Division of Tyco Healthc · Nov 2002
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
K020779 · Ethicon Endo-Surgery, Inc. · Jun 2002
ENDOANCHOR AND OPENANCHOR
K013749 · Ethicon Endo-Surgery, Inc. · Feb 2002
AUTO SUTURE SURGICAL STAPLES
K013860 · United States Surgical, A Division of Tyco Healthc · Dec 2001
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc · Dec 2000