K103235 is an FDA 510(k) clearance for the ERBEFLO 2 DISPOSABLE TUBING SYSTEM. This device is classified as a Endoscopic Irrigation/suction System (Class II - Special Controls, product code OCX).
Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on December 23, 2010, 51 days after receiving the submission on November 2, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures..
| 510(k) Number | K103235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2010 |
| Decision Date | December 23, 2010 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCX — Endoscopic Irrigation/suction System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures. |