The following data is part of a premarket notification filed by Medi-globe Corporation with the FDA for Sonotip Pro And Pro Flex Ebus-tbna Needle System.
| Device ID | K133763 |
| 510k Number | K133763 |
| Device Name: | SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM |
| Classification | Biopsy Needle |
| Applicant | MEDI-GLOBE CORPORATION 110 WEST ORION STREET Tempe, AZ 85283 |
| Contact | Scott Karler |
| Correspondent | Scott Karler MEDI-GLOBE CORPORATION 110 WEST ORION STREET Tempe, AZ 85283 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-11 |
| Decision Date | 2014-05-15 |
| Summary: | summary |