Home / 510(k) Clearances / K862358

510(k) K862358

EPICATH by Hdc Corp. — Product Code KNE

K862358 is an FDA 510(k) premarket notification submitted by Hdc Corp. for the device "EPICATH". The FDA issued a decision of Substantially Equivalent on July 7, 1986. The device falls under product code KNE (Set, Anesthesia, Obstetric), a Class II device regulated under 21 CFR 884.5100. Hdc Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1986
Date Received
June 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Anesthesia, Obstetric
Device Class
Class II
Regulation Number
884.5100
Review Panel
OB
Submission Type

Other clearances by Hdc Corp.

  • K091390 — HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 (July 30, 2009)
  • K071875 — V-CATH POLY PICC (November 5, 2007)
  • K071851 — HDC STERILE SPIDER SCREW (October 18, 2007)
  • K052471 — HDC SPIDER SCREW (December 23, 2005)
  • K023342 — NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE (March 2, 2004)
  • K033853 — MODIFICATION TO V-CATH POLY PICC (January 14, 2004)
  • K032404 — SELDINGER SAFETY NEEDLE INTRODUCER (September 10, 2003)
  • K022752 — PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-1 (September 9, 2003)
  • K022099 — SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390- (September 20, 2002)
  • K010425 — EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) (March 15, 2001)

Other clearances for product code KNE

  • K880988 — PUDENDAL/LOCAL ANESTESIA BLOCK TRAY (June 1, 1988)

FDA data resources