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510(k) K760203

TUBE, STERILE NON-CONDUCTIVE CONNECTING by Ipco Corp. — Product Code GCD

K760203 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "TUBE, STERILE NON-CONDUCTIVE CONNECTING". The FDA issued a decision of Substantially Equivalent on July 19, 1976. The device falls under product code GCD (Connector, Catheter), a Class I device regulated under 21 CFR 878.4200. Ipco Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1976
Date Received
July 8, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Ipco Corp.

  • K871270 — PERFORM DENTURE BASE RESIN (May 29, 1987)
  • K850666 — STROBEX ULTRON ELECTROSURGE-DENTAL UNIT (May 29, 1985)
  • K850906 — TACTILE PLUS DENTAL ELEVATORS (April 12, 1985)
  • K842836 — SAFE & SOFT MINI PADS & MAXI PADS (October 15, 1984)
  • K842837 — SAFE & SOFT MAXI SHILEDS (October 15, 1984)
  • K842838 — SAFE & SOFT PANTY SHIELDS (October 5, 1984)
  • K841953 — ULTRA SHIELD BRIEFS (July 19, 1984)
  • K840753 — AMBEZE DISPOSABLE INCONTINENCE PANTS (April 13, 1984)
  • K840754 — MAXISHIELD INCONTINENCE CARE SYSTEM (April 13, 1984)
  • K840755 — MINIGARD DISPOSABLE LINERS (April 13, 1984)

Other clearances for product code GCD

  • K952470 — ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (November 28, 1995)
  • K940198 — L-CATH CONNECTOR ASSEMBLY (December 15, 1994)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K851196 — INCISION DRAIN (June 4, 1985)
  • K851921 — Y CONNECTOR (May 17, 1985)
  • K760382 — CONNECTORS (November 2, 1976)
  • K760524 — CATHETER CONNECTOR, ARGYLE TUBING (November 2, 1976)

FDA data resources