Cleared Traditional

K030411 - PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03

K030411 is an FDA 510(k) clearance for PROXIMATE PPH HEMORRHOIDAL CIRCULAR STA..., manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K030411 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
41d
Days
Class 2
Risk

K030411 is an FDA 510(k) clearance for the PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 20, 2003 after a review of 41 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 Ethicon Endo-Surgery, Inc. devices

FDA 510(k) Submission Details - K030411

510(k) Number K030411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2003
Decision Date March 20, 2003
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
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 184
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K030411.
BIOMARC TISSUE MARKER
K032347 · Carbon Medical Technologies, Inc. · Aug 2003
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
K030925 · Ethicon Endo-Surgery, Inc. · May 2003
SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS
K030653 · Power Medical Interventions, Inc. · Mar 2003
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K024275 · United States Surgical, A Division of Tyco Healthc · Mar 2003
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V
K022313 · Power Medical Interventions, Inc. · Dec 2002
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · United States Surgical, A Division of Tyco Healthc · Nov 2002