Adaptor, Catheter
The Adaptor, Catheter (product code GCE) is an accessory fitting used to connect catheters or tubing of different sizes or configurations, enabling compatibility between components of a catheter-based system during surgical or clinical procedures. It is classified as FDA Class 1, posing minimal risk, subject only to general controls 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.
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Basic Information
- Product Code
- GCE
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K901716 | KLEIN CONNECTOR(TM) | May 11, 1990 | Substantially Equivalent | Jeff Klein Surgical, Inc. |
| K901715 | KLEIN CORK(TM) | May 11, 1990 | Substantially Equivalent | Jeff Klein Surgical, Inc. |
| K855039 | MEDIFLEX INJECTION CAP | Jan 24, 1986 | Substantially Equivalent | Mediflex Intl. |
| K801680 | BETA-CAP II ADAPTER | Aug 04, 1980 | Substantially Equivalent | Quinton, Inc. |
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.