FDA product code GBP: Catheter, Multiple Lumen
GBP is the FDA product code for catheter, multiple lumen. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under GBP, from 3 different applicants. The average 510(k) review took 62 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Multiple Lumen |
| 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 GBP clearance
Top GBP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Goosen Enterprises, Inc. | 1 | 1985-03-18 |
| Clincal Instruments Corp. | 1 | 1982-07-09 |
| Dlp, Inc. | 1 | 1982-03-11 |
Most recent GBP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844889 | Goosen Enterprises, Inc. | MENSINK-GOOSEN CATHETER | 1985-03-18 | 91 |
| K821220 | Clincal Instruments Corp. | MULTILUMEN INTRAVENOUS INFUSION CATHETER | 1982-07-09 | 73 |
| K820446 | Dlp, Inc. | CATHETER, MULTIPLE LUMEN | 1982-03-11 | 21 |
Recalls for GBP devices
openFDA lists no recalls for product code GBP.
Frequently asked questions
What is FDA product code GBP?
GBP is the FDA product code for catheter, multiple lumen. 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 GBP?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBP?
Across 3 cleared submissions the average was 62 days from receipt to decision (median 73).
Which companies have the most GBP clearances?
Goosen Enterprises, Inc. (1); Clincal Instruments Corp. (1); Dlp, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GBP
- Run a recall and safety report across every GBP manufacturer
- Watch product code GBP 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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