IRRIGATION SYSTEM
FDA 510(k) clearance K103239 · decided 2010-12-30
Clearance details
- K-number
- K103239
- Device name
- IRRIGATION SYSTEM
- Applicant
- United States Endoscopy Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-02
- Decision date
- 2010-12-30
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and acces recall (Z-1099-2013) | US Endoscopy Group Inc | 2013-04-11 |