510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862358Substantially Equivalent

Epicath

Hdc Corp., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862358 is the FDA 510(k) clearance record for EPICATH, a class II device, cleared for Hdc Corp. on under FDA product code KNE (Set, Anesthesia, Obstetric). FDA records list 9 510(k) clearances for Hdc Corp., from to . As of , FDA records show no recalls naming K862358.

Clearance record

Decision date
Received
(14 days to decision)
Product code
KNE Set, Anesthesia, Obstetric
Regulation
21 CFR 884.5100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hdc Corp. 2551 Casey Ave., Mountain View CA
Third party review
No

Clearances, product code KNE

Trailing 12 months

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

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