FDA product code PUP: Endoscope Maintenance System
PUP is the FDA product code for endoscope maintenance system. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under PUP. The average 510(k) review took 68 days (median 68).
Definition
To assist in disinfecting, rinsing and storing endoscopes or similar elongated instruments.
Classification
| Field | Value |
|---|---|
| Device name | Endoscope Maintenance System |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | HO — General Hospital |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PUP clearance
Top PUP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Buckman Co., Inc. | 1 | 1986-04-02 |
Most recent PUP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860246 | Buckman Co., Inc. | ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE | 1986-04-02 | 68 |
Recalls for PUP devices
openFDA lists no recalls for product code PUP.
Frequently asked questions
What is FDA product code PUP?
PUP is the FDA product code for endoscope maintenance system. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General Hospital panel.
What device class is PUP?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PUP?
Across 1 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most PUP clearances?
Buckman Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PUP
- Run a recall and safety report across every PUP manufacturer
- Watch product code PUP 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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