Cleared Special

K981669 - SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR

K981669 is an FDA 510(k) clearance for SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FHN cleared through the Special 510(k) pathway after a 23-day FDA review.

K981669 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
23d
Days
Class 2
Risk

K981669 is an FDA 510(k) clearance for the SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR. Classified as Ligator, Hemorrhoidal (product code FHN), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on June 4, 1998 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K981669

510(k) Number K981669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1998
Decision Date June 04, 1998
Days to Decision 23 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 131d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

FHN Device Classification - Class 2, Special Controls

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 K981669.
RIZA BAND STRETCHER (RBS)-60000
K001236 · R-Med, Inc. · Jul 2000
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
K000297 · Erchinger Medizintecnik · Apr 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K000397 · Boston Scientific Corp · Mar 2000
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
K974018 · Wilson-Cook Medical, Inc. · Jan 1998
O'REGAN LIGATOR
K963166 · Patrick J. O'Regan · May 1997
SPEEDBAND MULTIPLE BAND LIGATOR
K964079 · Boston Scientific Corp · Feb 1997
K981669 · SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
Download PDF FDA Summary Boston Scientific Corp