Cleared Traditional

K060623 - SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND...

K060623 is the FDA 510(k) clearance for SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND... by Cook Ireland, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FER) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K060623 · Cook Ireland, Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2006
Decision
182d
Days
Class 2
Risk

K060623 is an FDA 510(k) clearance for the SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on September 6, 2006 after a review of 182 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Cook Ireland, Ltd. devices

Submission Details

510(k) Number K060623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2006
Decision Date September 06, 2006
Days to Decision 182 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
52d slower than avg
Panel avg: 130d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
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 - FER Anoscope And Accessories

All 11
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K060623.
GELPOINT PATH TRANSANAL ACCESS PLATFORM
K133393 · Applied Medical Resources Corp. · Jan 2014
GELPOINT PATH
K110792 · Applied Medical Resources Corp. · May 2011
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · Ethicon Endo-Surgery, Inc. · Mar 2010
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · Baxter Healthcare Corp · Sep 1988
MODEL #53110 DISPOSABLE ANOSCOPE
K810227 · Welch Allyn, Inc. · Feb 1981
ANOSCOPE, OPTIC, FIBER
K770906 · Welch Allyn, Inc. · Jun 1977