510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K960020Substantially Equivalent

Solo Band Ligator

Surcraft, LLC, Newport News VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960020 is the FDA 510(k) clearance record for SOLO BAND LIGATOR, a class II device, cleared for Surcraft, LLC on under FDA product code FHN (Ligator, Hemorrhoidal). FDA records list one 510(k) clearance for Surcraft, LLC. As of , FDA records show no recalls naming K960020.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FHN Ligator, Hemorrhoidal
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surcraft, LLC Plz. One, Newport News VA
510(k) summary
Summary
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