510(k) K182188 ยท EOQ Bronchoscope (Flexible Or Rigid)
Ion Endoluminal System ; Flexision Biopsy Needle
| Applicant | Intuitive Surgical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 14, 2019 |
| Received | Aug 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2024 | Intuitive Surgical, Inc. Ion Endoluminal System, REF: 380748-65 Open, Classified |
EOQ | None listed |
| Aug 6, 2021 | Intuitive Surgical, Inc. Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978 Terminated |
EOQ | None listed |
| Oct 23, 2020 | Intuitive Surgical, Inc. Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target.
Use Terminated |
EOQ | None listed |
| Jun 10, 2020 | Intuitive Surgical, Inc. Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845. Open, Classified |
EOQ | None listed |
| Jun 10, 2020 | Intuitive Surgical, Inc. ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02). Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.