K042882 is an FDA 510(k) clearance for the ENTERYX INJECTION CATHETER. This device is classified as a Endoscopic Injection Needle, Gastroenterology-urology (Class II - Special Controls, product code FBK).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on November 9, 2004, 21 days after receiving the submission on October 19, 2004.
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 | K042882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2004 |
| Decision Date | November 09, 2004 |
| Days to Decision | 21 days |
| Submission Type | Special |
| 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. |