Cleared Traditional

O'REGAN LIGATOR (K963166) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963166 · Patrick J. O'Regan · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
264d
Days
Class 2
Risk

K963166 is an FDA 510(k) clearance for the O'REGAN LIGATOR. Classified as Ligator, Hemorrhoidal (product code FHN), Class II - Special Controls.

Submitted by Patrick J. O'Regan (Vancouver, CA). The FDA issued a Cleared decision on May 5, 1997 after a review of 264 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - the FDA gastroenterology and urology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Patrick J. O'Regan devices

Submission Details

510(k) Number K963166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1996
Decision Date May 05, 1997
Days to Decision 264 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 130d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FHN Ligator, Hemorrhoidal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FHN Ligator, Hemorrhoidal

All 21
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K963166.
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SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
K020824 · Boston Scientific Corp · Apr 2002
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K000397 · Boston Scientific Corp · Mar 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
K981669 · Boston Scientific Corp · Jun 1998
SPEEDBAND MULTIPLE BAND LIGATOR
K964079 · Boston Scientific Corp · Feb 1997