Tube, Sterile Non-Conductive Connecting
FDA 510(k) K760203 · Ipco Corp.
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)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K952470 | Acti-Flex Low, Medium, Rescare I, Rescare Ii.GCD · Traditional | R-Group Intl. | 11/28/1995SE |
| K940198 | L-Cath Connector AssemblyGCD · Traditional | Luther Medical Products, Inc. | 12/15/1994SE |
| K863446 | Angiomed High Pressure ConnectorsGCD · Traditional | Angiomed U.S., Inc. | 09/23/1986SE |
| K851196 | Incision DrainGCD · Traditional | Sil-Med Corp. | 06/04/1985SE |
| K851921 | Y ConnectorGCD · Traditional | Sil-Med Corp. | 05/17/1985SE |
| K760524 | Catheter Connector, Argyle TubingGCD · Traditional | Sherwood Medical Industries | 11/02/1976SE |
| K760382 | ConnectorsGCD · Traditional | B. Braun Instruments | 11/02/1976SE |
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| K841953 | Ultra Shield BriefsEYQ · Traditional | 07/19/1984SE |
| K840755 | Minigard Disposable LinersEYQ · Traditional | 04/13/1984SE |
| K840754 | Maxishield Incontinence Care SystemEYQ · Traditional | 04/13/1984SE |
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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.