510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193664Substantially Equivalent

SubQKath Catheter and Needle Set

HK Surgical Inc, San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193664 is the FDA 510(k) clearance record for SubQKath Catheter and Needle Set, a class II device, cleared for Hk Surgical on under FDA product code BSO (Catheter, Conduction, Anesthetic). FDA records list 4 510(k) clearances for Hk Surgical, from to . As of , FDA records show no recalls naming K193664.

Clearance record

Decision date
Received
(253 days to decision)
Product code
BSO Catheter, Conduction, Anesthetic
Regulation
21 CFR 868.5120
Device class
Class II
Review panel
Anesthesiology
Applicant
Hk Surgical 1271 Puerto Del Sol, San Clemente CA
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