510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880648Substantially Equivalent

Endoscopic Elastic Band Ligator

Superior Healthcare Group, Inc., Cumberland RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880648 is the FDA 510(k) clearance record for ENDOSCOPIC ELASTIC BAND LIGATOR, a class II device, cleared for Superior Healthcare Group, Inc. on under FDA product code FHN (Ligator, Hemorrhoidal). FDA records list 14 510(k) clearances for Superior Healthcare Group, Inc., from to . As of , FDA records show no recalls naming K880648.

Clearance record

Decision date
Received
(49 days to decision)
Product code
FHN Ligator, Hemorrhoidal
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Superior Healthcare Group, Inc. Cumberland Industrial Park, Cumberland RI
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