510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020824Substantially Equivalent

Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238

Boston Scientific Corporation, Natick, MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020824 is the FDA 510(k) clearance record for SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238, a class II device, cleared for Boston Scientific Corp on under FDA product code FHN (Ligator, Hemorrhoidal). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K020824.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FHN Ligator, Hemorrhoidal
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp One Boston Scientific Pl., Natick, MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FHN

Trailing 12 months

FDA records hold no clearances under product code FHN in the trailing twelve months.

FDA records show no clearances under product code FHN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FHN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260