FDA product code ODA: Endoscopic Central Control Unit
ODA is the FDA product code for endoscopic central control unit. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 18 510(k) submissions under ODA, 2 in the last five years, from 10 different applicants. The average 510(k) review took 134 days (median 122).
Definition
To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Central Control Unit |
| 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 ODA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 142 |
| 2021 | 1 | 157 |
| 2022 | 1 | 67 |
| 2023 | 1 | 54 |
Compare with all 510(k) review times · Search every ODA clearance
Top ODA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 5 | 2012-01-06 |
| Olympus Medical Systems Corporation | 3 | 2011-02-15 |
| Smith & Nephew | 2 | 2021-05-13 |
| Richard Wolf Medical Instruments Corp. | 2 | 2016-01-12 |
| Karl Storz SE & CO. KG | 1 | 2023-10-03 |
5 more applicants have ODA clearances. See the full list in Caduvo.
Most recent ODA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232406 | Karl Storz SE & CO. KG | KARL STORZ OR1 SCB CONTROL (WU300) | 2023-10-03 | 54 |
| K221929 | Smith+Nephew | Smith+Nephew INTELLIO Tablet | 2022-09-06 | 67 |
| K203566 | Smith & Nephew | Tablet Application | 2021-05-13 | 157 |
| K192876 | Smith & Nephew | INTELLIO Tablet Application | 2020-02-27 | 142 |
| K153205 | Black Diamond Video, Inc. | IDSS ForceTriad Control Module | 2016-08-01 | 271 |
Recalls for ODA devices
openFDA lists no recalls for product code ODA.
Frequently asked questions
What is FDA product code ODA?
ODA is the FDA product code for endoscopic central control unit. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is ODA?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODA?
Across 18 cleared submissions the average was 134 days from receipt to decision (median 122).
Which companies have the most ODA clearances?
KARL STORZ Endoscopy-America, Inc. (5); Olympus Medical Systems Corporation (3); Smith & Nephew (2); Richard Wolf Medical Instruments Corp. (2); Karl Storz SE & CO. KG (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ODA
- Run a recall and safety report across every ODA manufacturer
- Watch product code ODA 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times