FDA product code FIG: Clamp, Tubing, Blood, Automatic
FIG is the FDA product code for clamp, tubing, blood, automatic. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FIG, from 3 different applicants. The average 510(k) review took 378 days (median 435).
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Tubing, Blood, Automatic |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FIG clearance
Top FIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rocky Mountain Research, Inc. | 2 | 1994-01-05 |
| Deka Research & Development Corp. | 1 | 2011-08-23 |
| Cordis Corp. | 1 | 1977-04-15 |
Most recent FIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093915 | Deka Research & Development Corp. | DEKA TAC DEVICE | 2011-08-23 | 609 |
| K921993 | Rocky Mountain Research, Inc. | ELS AUTOMATIC TUBING CLAMP SYSTEM | 1994-01-05 | 617 |
| K914459 | Rocky Mountain Research, Inc. | AUTOMATIC TUBING CLAMP | 1992-06-24 | 261 |
| K770535 | Cordis Corp. | C-DAK 3500 | 1977-04-15 | 25 |
Recalls for FIG devices
openFDA lists no recalls for product code FIG.
Frequently asked questions
What is FDA product code FIG?
FIG is the FDA product code for clamp, tubing, blood, automatic. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIG?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIG?
Across 4 cleared submissions the average was 378 days from receipt to decision (median 435).
Which companies have the most FIG clearances?
Rocky Mountain Research, Inc. (2); Deka Research & Development Corp. (1); Cordis Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FIG
- Run a recall and safety report across every FIG manufacturer
- Watch product code FIG 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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