Cleared Traditional

K013889 - ENDOSCOPIC MULTI-FIRE CLIP APPLIER

K013889 is an FDA 510(k) clearance for ENDOSCOPIC MULTI-FIRE CLIP APPLIER, manufactured by Inscope, LLC. The device is a Class 2 Gastroenterology & Urology device with product code PKL cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K013889 · Inscope, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
76d
Days
Class 2
Risk

K013889 is an FDA 510(k) clearance for the ENDOSCOPIC MULTI-FIRE CLIP APPLIER. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Inscope, LLC (Miami, US). The FDA issued a Cleared decision on February 7, 2002 after a review of 76 days - a notably fast clearance 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: 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 Inscope, LLC devices

FDA 510(k) Submission Details - K013889

510(k) Number K013889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date February 07, 2002
Days to Decision 76 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
54d faster than avg
Panel avg: 130d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PKL Device Classification - Class 2, Special Controls

Product Code PKL Hemostatic Metal Clip For The Gi Tract
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
Definition Clip Placement Within The Gastrointestinal (gi) Tract For The Purpose Of Endoscopic Marking, Hemostasis For Mucosal/sub-mucosal Defects, Bleeding Ulcers, Arteries, Polyps, Diverticula In The Colon, Prophylactic Clipping, Anchoring Feeding Tubes, Supplemental Closure Method Of Luminal Perforations.
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 - PKL Hemostatic Metal Clip For The Gi Tract

All 55
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K013889.
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
K122660 · Boston Scientific Corporation · Dec 2012
RESOLUTION II CLIP
K102764 · Boston Scientific Corporation · Dec 2010
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
K023903 · Wilson-Cook Medical, Inc. · Feb 2003
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K963160 · Olympus America, Inc. · Jun 1997