510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130489Substantially Equivalent

Electrode, Flexible Suction Coagulator

Optim LLC, Sturbridge MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130489 is the FDA 510(k) clearance record for ELECTRODE, FLEXIBLE SUCTION COAGULATOR, a class II device, cleared for Optim, LLC on under FDA product code FEH (Electrode, Flexible Suction Coagulator). FDA records list 6 510(k) clearances for Optim, LLC, from to . As of , FDA records show no recalls naming K130489.

Clearance record

Decision date
Received
(53 days to decision)
Product code
FEH Electrode, Flexible Suction Coagulator
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Optim, LLC 64 Technology Park Rd., Sturbridge MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEH

Trailing 12 months

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

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