FDA product code PID: Esophageal Dilator Balloon With Or Without Electrode Sensors
PID is the FDA product code for esophageal dilator balloon with or without electrode sensors. 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 PID, from 3 different applicants. The average 510(k) review took 71 days (median 73). FDA has posted 1 recall for PID devices, 1 initiated in the last five years.
Definition
To dilate the lower esophageal sphincter of patients with Achalasia.
Classification
| Field | Value |
|---|---|
| Device name | Esophageal Dilator Balloon With Or Without Electrode Sensors |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PID
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 102 |
Compare with all 510(k) review times · Search every PID clearance
Top PID applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wilson-Cook Medical, Inc. | 1 | 2019-01-25 |
| Crospon, Ltd. | 1 | 2013-10-07 |
| Boston Scientific Corp | 1 | 2005-03-11 |
Most recent PID clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182895 | Wilson-Cook Medical, Inc. | Wilson-Cook Achalasia Balloon | 2019-01-25 | 102 |
| K132337 | Crospon, Ltd. | ESOFLIP BALLOON DILATION CATHETER | 2013-10-07 | 73 |
| K050232 | Boston Scientific Corp | RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR | 2005-03-11 | 38 |
Recalls for PID devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-04-25.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code PID?
PID is the FDA product code for esophageal dilator balloon with or without electrode sensors. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is PID?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code PID?
Across 3 cleared submissions the average was 71 days from receipt to decision (median 73).
Which companies have the most PID clearances?
Wilson-Cook Medical, Inc. (1); Crospon, Ltd. (1); Boston Scientific Corp (1).
Have PID devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-04-25.
Next steps
- Run an FDA pathway report with predicate devices for product code PID
- Run a recall and safety report across every PID manufacturer
- Watch product code PID 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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