FDA product code ODB: Endoscopic Contamination Prevention Sheath
ODB is the FDA product code for endoscopic contamination prevention sheath. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under ODB, from 5 different applicants. The average 510(k) review took 123 days (median 103).
Definition
To protect an endoscope from contamination by providing a barrier between the body and the endoscope.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Contamination Prevention Sheath |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for ODB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 326 |
Top ODB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gi Scientific, LLC | 1 | 2019-10-08 |
| Lumenr, LLC | 1 | 2016-04-19 |
| Minos Medical | 1 | 2008-06-10 |
| Olympus Medical Systems Corporation | 1 | 2006-03-17 |
| Karl Storz Endoskop GmbH | 1 | 1994-09-14 |
Most recent ODB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183171 | Gi Scientific, LLC | ScopeSeal Duodenoscope Protective Device | 2019-10-08 | 326 |
| K153698 | Lumenr, LLC | LumenR Tissue Retractor System | 2016-04-19 | 118 |
| K080550 | Minos Medical | MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 | 2008-06-10 | 103 |
| K060475 | Olympus Medical Systems Corporation | EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 | 2006-03-17 | 22 |
| K943697 | Karl Storz Endoskop GmbH | TROCARS,CANNULAE,SHEATHS,OBTURATORS | 1994-09-14 | 47 |
Recalls for ODB devices
openFDA lists no recalls for product code ODB.
Frequently asked questions
What is FDA product code ODB?
ODB is the FDA product code for endoscopic contamination prevention sheath. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is ODB?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODB?
Across 5 cleared submissions the average was 123 days from receipt to decision (median 103).
Which companies have the most ODB clearances?
Gi Scientific, LLC (1); Lumenr, LLC (1); Minos Medical (1); Olympus Medical Systems Corporation (1); Karl Storz Endoskop GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ODB
- Run a recall and safety report across every ODB manufacturer
- Watch product code ODB 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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