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) Official FDA 510(k) Summary (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.

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 21
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K020824.
THD BANDY
K093497 · Thd Spa · Jul 2010
HAEMOBAND MULTI-LIGATOR
K091519 · Haemoband Surgical, Ltd. · Jul 2009
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
K070881 · Sapimed S.P.A. · Sep 2007
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
K020526 · Don Wilson/Wilson-Cook Medical, Inc. · Mar 2002
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
K020824 · SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
Download PDF FDA Summary Boston Scientific Corp