The following data is part of a premarket notification filed by Intuitive Surgical with the FDA for Ion Endoluminal System ; Flexision Biopsy Needle.
| Device ID | K182188 |
| 510k Number | K182188 |
| Device Name: | Ion Endoluminal System ; Flexision Biopsy Needle |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 |
| Contact | Sarah Rizk |
| Correspondent | Sarah Rizk Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-13 |
| Decision Date | 2019-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874119334 | K182188 | 000 |
| 10886874116125 | K182188 | 000 |
| 10886874115975 | K182188 | 000 |
| 10886874115968 | K182188 | 000 |
| 10886874115951 | K182188 | 000 |
| 00886874119129 | K182188 | 000 |
| 00886874116913 | K182188 | 000 |
| 00886874116258 | K182188 | 000 |
| 10886874116118 | K182188 | 000 |
| 30886874119847 | K182188 | 000 |
| 10886874116200 | K182188 | 000 |
| 00886874116234 | K182188 | 000 |
| 00886874116241 | K182188 | 000 |
| 00886874119327 | K182188 | 000 |
| 00886874119143 | K182188 | 000 |
| 00886874119082 | K182188 | 000 |
| 00886874116975 | K182188 | 000 |
| 00886874116852 | K182188 | 000 |
| 00886874116845 | K182188 | 000 |
| 00886874116630 | K182188 | 000 |
| 00886874116289 | K182188 | 000 |
| 00886874116272 | K182188 | 000 |
| 30886874119830 | K182188 | 000 |