510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K010425Substantially Equivalent

Epidural Catheter with Connector (and Accessory)

Hdc Corp., San Jose CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010425 is the FDA 510(k) clearance record for EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY), a class II device, cleared for Hdc Corp. on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list 12 510(k) clearances for Hdc Corp., from to . As of , FDA records show no recalls naming K010425.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hdc Corp. 2109 O'Toole Ave., San Jose CA
510(k) summary
Statement
Third party review
No

Clearances, product code KNF

Trailing 12 months
1 clearance under product code KNF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNF, 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 20261
October 20260