Cleared Special

K021249 - SURGASSIST FLEXSHAFT 2

K021249 is an FDA 510(k) clearance for SURGASSIST FLEXSHAFT 2, 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 26-day FDA review.

K021249 · Power Medical Interventions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
26d
Days
Class 2
Risk

K021249 is an FDA 510(k) clearance for the SURGASSIST FLEXSHAFT 2, MODEL FS2 14. 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 15, 2002 after a review of 26 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 - K021249

510(k) Number K021249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date May 15, 2002
Days to Decision 26 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
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 173
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K021249.
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