510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981329Substantially Equivalent

Feth-R-Kath

Epimed International, Inc., Gloversville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981329 is the FDA 510(k) clearance record for FETH-R-KATH, a class II device, cleared for Epimed International, Inc. on under FDA product code BSO (Catheter, Conduction, Anesthetic). FDA records list 16 510(k) clearances for Epimed International, Inc., from to . As of , FDA records show 2 recalls naming K981329.

Clearance record

Decision date
Received
(135 days to decision)
Product code
BSO Catheter, Conduction, Anesthetic
Regulation
21 CFR 868.5120
Device class
Class II
Review panel
Anesthesiology
Applicant
Epimed International, Inc. P.O. Box 1128, Gloversville NY
510(k) summary
Summary
Third party review
No

Clearances, product code BSO

Trailing 12 months

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

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