Cleared Special

K020824 - SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238

K020824 is an FDA 510(k) clearance for SPEEDBAND SUPERVIEW SUPER 7, 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 29-day FDA review.

K020824 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
29d
Days
Class 2
Risk

K020824 is an FDA 510(k) clearance for the SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 42.... 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 April 12, 2002 after a review of 29 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.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K020824

510(k) Number K020824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2002
Decision Date April 12, 2002
Days to Decision 29 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
102d faster than avg
Panel avg: 131d · This submission: 29d
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 13
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K020824.
Ligation Device
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K131282 · Inx Medical · Jul 2013
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
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
K974018 · Wilson-Cook Medical, Inc. · Jan 1998