Tube, Sterile Non-Conductive Connecting

FDA 510(k) K760203 · Ipco Corp.

Substantially Equivalent

510(k) numberK760203

Submission

Device name
Tube, Sterile Non-Conductive Connecting
Applicant
Ipco Corp.
Mchenry, IL, US
Received
July 8, 1976
Decision date
July 19, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GCD – Connector, Catheter
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Specialty
General, Plastic Surgery

Other 510(k)s with product code GCD

510(k)DeviceApplicantDecision
K952470Acti-Flex Low, Medium, Rescare I, Rescare Ii.GCD · Traditional R-Group Intl.11/28/1995SE
K940198L-Cath Connector AssemblyGCD · Traditional Luther Medical Products, Inc.12/15/1994SE
K863446Angiomed High Pressure ConnectorsGCD · Traditional Angiomed U.S., Inc.09/23/1986SE
K851196Incision DrainGCD · Traditional Sil-Med Corp.06/04/1985SE
K851921Y ConnectorGCD · Traditional Sil-Med Corp.05/17/1985SE
K760524Catheter Connector, Argyle TubingGCD · Traditional Sherwood Medical Industries11/02/1976SE
K760382ConnectorsGCD · Traditional B. Braun Instruments11/02/1976SE

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Questions and answers

When was Tube, Sterile Non-Conductive Connecting cleared by the FDA?

Tube, Sterile Non-Conductive Connecting (K760203) received a 510(k) decision of Substantially Equivalent on July 19, 1976, 11 days after the submission was received.

What is the product code of K760203?

The FDA product code is GCD – Connector, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.