FDA product code GBT: Catheter, Rectal
GBT is the FDA product code for catheter, rectal. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under GBT, from 3 different applicants. The average 510(k) review took 270 days (median 212). FDA has posted 1 recall for GBT devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Rectal |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GBT clearance
Top GBT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovatec Medical Corp. | 1 | 1994-10-20 |
| Tri-Med Specialties, Inc. | 1 | 1994-02-10 |
| Tonometrics, Inc. | 1 | 1989-04-21 |
Most recent GBT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941391 | Innovatec Medical Corp. | INFLATABLE RETENTION CUFF SPECULUM | 1994-10-20 | 212 |
| K924549 | Tri-Med Specialties, Inc. | TRI-MED QUICK-STEP(TM) RECTAL TUBE | 1994-02-10 | 519 |
| K890466 | Tonometrics, Inc. | SIGMOID TONOMITOR | 1989-04-21 | 80 |
Recalls for GBT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-06-14.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code GBT?
GBT is the FDA product code for catheter, rectal. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is GBT?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code GBT?
Across 3 cleared submissions the average was 270 days from receipt to decision (median 212).
Which companies have the most GBT clearances?
Innovatec Medical Corp. (1); Tri-Med Specialties, Inc. (1); Tonometrics, Inc. (1).
Have GBT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-06-14.
Next steps
- Run an FDA pathway report with predicate devices for product code GBT
- Run a recall and safety report across every GBT manufacturer
- Watch product code GBT 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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