Connector, Catheter
The Connector, Catheter (product code GCD) is an accessory component used to join two sections of catheter tubing together or connect a catheter to another device, maintaining a fluid-tight seal during surgical or clinical procedures. It is classified as FDA Class 1, the lowest risk level, subject to general controls only and not requiring premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
Research product code GCD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- GCD
- Device Class
- FDA class 1
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952470 | ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. | Nov 28, 1995 | Substantially Equivalent | R-Group Intl. |
| K940198 | L-CATH CONNECTOR ASSEMBLY | Dec 15, 1994 | Substantially Equivalent | Luther Medical Products, Inc. |
| K863446 | ANGIOMED HIGH PRESSURE CONNECTORS | Sep 23, 1986 | Substantially Equivalent | Angiomed U.S., Inc. |
| K851196 | INCISION DRAIN | Jun 04, 1985 | Substantially Equivalent | Sil-Med Corp. |
| K851921 | Y CONNECTOR | May 17, 1985 | Substantially Equivalent | Sil-Med Corp. |
| K760524 | CATHETER CONNECTOR, ARGYLE TUBING | Nov 02, 1976 | Substantially Equivalent | Sherwood Medical Industries |
| K760382 | CONNECTORS | Nov 02, 1976 | Substantially Equivalent | B. Braun Instruments |
| K760203 | TUBE, STERILE NON-CONDUCTIVE CONNECTING | Jul 19, 1976 | Substantially Equivalent | Ipco Corp. |
FEI Numbers
This FDA classification entry is associated with 69 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 69 registration numbers. Click on an entry to view related FDA registrations.