FDA product code GBQ: Catheter, Continuous Irrigation
GBQ is the FDA product code for catheter, continuous irrigation. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under GBQ, from 8 different applicants. The average 510(k) review took 38 days (median 35). FDA has posted 1 recall for GBQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Continuous Irrigation |
| 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 GBQ clearance
Top GBQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jedmed Instrument Co. | 1 | 1994-05-19 |
| Trinity Laboratories, Inc. | 1 | 1992-05-05 |
| Gesco Intl., Inc. | 1 | 1988-09-09 |
| Specialty Medical Products Co. | 1 | 1987-12-02 |
| Ipax, Inc. | 1 | 1987-09-04 |
3 more applicants have GBQ clearances. See the full list in Caduvo.
Most recent GBQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941356 | Jedmed Instrument Co. | MICROFLOW IRRIGATION SYSTEM | 1994-05-19 | 59 |
| K921464 | Trinity Laboratories, Inc. | CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT | 1992-05-05 | 39 |
| K882647 | Gesco Intl., Inc. | GESCO CATHETERIZATION TRAY | 1988-09-09 | 74 |
| K874596 | Specialty Medical Products Co. | PERFORATED SOAKING TUBE | 1987-12-02 | 23 |
| K873097 | Ipax, Inc. | PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS | 1987-09-04 | 39 |
Recalls for GBQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-06-29.
Frequently asked questions
What is FDA product code GBQ?
GBQ is the FDA product code for catheter, continuous irrigation. 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 GBQ?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBQ?
Across 8 cleared submissions the average was 38 days from receipt to decision (median 35).
Which companies have the most GBQ clearances?
Jedmed Instrument Co. (1); Trinity Laboratories, Inc. (1); Gesco Intl., Inc. (1); Specialty Medical Products Co. (1); Ipax, Inc. (1).
Have GBQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-06-29.
Next steps
- Run an FDA pathway report with predicate devices for product code GBQ
- Run a recall and safety report across every GBQ manufacturer
- Watch product code GBQ 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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