Cleared Traditional

K991030 - PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES

K991030 is an FDA 510(k) clearance for PROXIMATE HCS 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 49-day FDA review.

K991030 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
49d
Days
Class 2
Risk

K991030 is an FDA 510(k) clearance for the PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES. 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 May 17, 1999 after a review of 49 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 - K991030

510(k) Number K991030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date May 17, 1999
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 K991030.
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
K012809 · Power Medical Interventions, Inc. · Oct 2001
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc · Dec 2000
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
K000060 · Senorx, Inc. · Mar 2000
AUTO SUTURE SITE MARKER CLIP
K983400 · United States Surgical, A Division of Tyco Healthc · Feb 1999
PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
K983536 · Ethicon Endo-Surgery, Inc. · Dec 1998
AUTO SUTURE* MODIFIED LINEAR STAPLER**
K952239 · United States Surgical, A Division of Tyco Healthc · Oct 1995