510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133316Substantially Equivalent

Spirol Block (19 Ga. Open End Models), (20 Ga. Open End Models), (19 Ga. Closed End Models), (20 Ga. Closed End Models)

Epimed International, Inc., Johnstown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133316 is the FDA 510(k) clearance record for SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS), 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 no recalls naming K133316.

Clearance record

Decision date
Received
(212 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. 141 Sal Landrio Dr. Crossroads Business Park, Johnstown NY
510(k) summary
Summary PDF
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