K090830 is an FDA 510(k) clearance for the LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP. This device is classified as a Endoscopic Injection Needle, Gastroenterology-urology (Class II - Special Controls, product code FBK).
Submitted by Laborie Medical Technologies, Ltd. (Williston, US). The FDA issued a Cleared decision on July 21, 2009, 117 days after receiving the submission on March 26, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue..
| 510(k) Number | K090830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2009 |
| Decision Date | July 21, 2009 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBK — Endoscopic Injection Needle, Gastroenterology-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue. |