FDA product code PLI: Gastrointestional Tube Holder
PLI is the FDA product code for gastrointestional tube holder. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under PLI. The average 510(k) review took 90 days (median 90).
Definition
Intended to support, secure, and hold gastrointestinal tubes
Classification
| Field | Value |
|---|---|
| Device name | Gastrointestional Tube Holder |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PLI clearance
Top PLI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dale Medical Products, Inc. | 1 | 1996-07-30 |
Most recent PLI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961693 | Dale Medical Products, Inc. | DALE GASTROSTOMY TUBE HOLDER | 1996-07-30 | 90 |
Recalls for PLI devices
openFDA lists no recalls for product code PLI.
Frequently asked questions
What is FDA product code PLI?
PLI is the FDA product code for gastrointestional tube holder. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is PLI?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PLI?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most PLI clearances?
Dale Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PLI
- Run a recall and safety report across every PLI manufacturer
- Watch product code PLI 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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