510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083556Substantially Equivalent

Modification to Auto-Band Ligator

Scandimed International, Jamestown RI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083556 is the FDA 510(k) clearance record for MODIFICATION TO AUTO-BAND LIGATOR, a class II device, cleared for Scandimed International on under FDA product code MND (Ligator, Esophageal). FDA records list 2 510(k) clearances for Scandimed International, from to . As of , FDA records show no recalls naming K083556.

Clearance record

Decision date
Received
(79 days to decision)
Product code
MND Ligator, Esophageal
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Scandimed International 29 Frigate St., Jamestown RI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MND

Trailing 12 months

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

FDA records show no clearances under product code MND in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MND, 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