FDA product code GCE: Adaptor, Catheter
GCE is the FDA product code for adaptor, catheter. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under GCE, from 3 different applicants. The average 510(k) review took 27 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Catheter |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GCE clearance
Top GCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jeff Klein Surgical, Inc. | 2 | 1990-05-11 |
| Mediflex Intl. | 1 | 1986-01-24 |
| Quinton, Inc. | 1 | 1980-08-04 |
Most recent GCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901715 | Jeff Klein Surgical, Inc. | KLEIN CORK(TM) | 1990-05-11 | 28 |
| K901716 | Jeff Klein Surgical, Inc. | KLEIN CONNECTOR(TM) | 1990-05-11 | 28 |
| K855039 | Mediflex Intl. | MEDIFLEX INJECTION CAP | 1986-01-24 | 38 |
| K801680 | Quinton, Inc. | BETA-CAP II ADAPTER | 1980-08-04 | 13 |
Recalls for GCE devices
openFDA lists no recalls for product code GCE.
Frequently asked questions
What is FDA product code GCE?
GCE is the FDA product code for adaptor, catheter. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is GCE?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GCE?
Across 4 cleared submissions the average was 27 days from receipt to decision (median 28).
Which companies have the most GCE clearances?
Jeff Klein Surgical, Inc. (2); Mediflex Intl. (1); Quinton, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GCE
- Run a recall and safety report across every GCE manufacturer
- Watch product code GCE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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