FDA product code ODF: Mini Endoscope, Gastroenterology-Urology
ODF is the FDA product code for mini endoscope, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 12 510(k) submissions under ODF, from 8 different applicants. The average 510(k) review took 109 days (median 91).
Definition
To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Mini Endoscope, Gastroenterology-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every ODF clearance
Top ODF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 3 | 2009-02-04 |
| Candela Laser Corp. | 3 | 1994-06-17 |
| C-Link Micro Imaging, Inc. | 1 | 2010-01-12 |
| Lumenis, Inc. | 1 | 2009-09-30 |
| Five Star Medical, Inc. | 1 | 1997-09-08 |
3 more applicants have ODF clearances. See the full list in Caduvo.
Most recent ODF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092739 | C-Link Micro Imaging, Inc. | MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE | 2010-01-12 | 126 |
| K091962 | Lumenis, Inc. | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 | 2009-09-30 | 91 |
| K090170 | Boston Scientific Corp | SPYSCOPE ACCESS AND DELIVERY CATHETER | 2009-02-04 | 12 |
| K052194 | Boston Scientific Corp | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR | 2005-08-24 | 13 |
| K050403 | Boston Scientific Corp | SPYGLASS DIRECT VISULATION PROBE | 2005-03-04 | 15 |
Recalls for ODF devices
openFDA lists no recalls for product code ODF.
Frequently asked questions
What is FDA product code ODF?
ODF is the FDA product code for mini endoscope, gastroenterology-urology. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is ODF?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODF?
Across 12 cleared submissions the average was 109 days from receipt to decision (median 91).
Which companies have the most ODF clearances?
Boston Scientific Corp (3); Candela Laser Corp. (3); C-Link Micro Imaging, Inc. (1); Lumenis, Inc. (1); Five Star Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ODF
- Run a recall and safety report across every ODF manufacturer
- Watch product code ODF 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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