510(k) K122106 ยท JAK System, X-Ray, Tomography, Computed
SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
| Applicant | Veran Medical Technologies, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Dec 21, 2012 |
| Received | Jul 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2023 | Olympus Corporation of the Americas Veran:SPiN Thoracic Navigation System
Models:
SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz
SYS-4000 SPiN Thoracic Navigation System
SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Na Open, Classified |
JAK | None listed |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Percutaneous
Models:
INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)"
INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx
INS-5610 SPiN Perc Localization N Open, Classified |
JAK | None listed |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Endobronchial
Models:
INS-5500 View Optical Probe
INS-5450 SPiN Xtend 21ga, 1.8 OD, 5/Bx
INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC
INS-5411 0.016" Stylet, 1235 mm L, Open, Classified |
JAK | None listed |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Percutaneous Always on Track
Models:
INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga
INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga
INS-5036 "22 UTW 125mm Always- Open, Classified |
JAK | None listed |
| Sep 29, 2023 | Olympus Corporation of the Americas Veran : Endobronchial Always on Track
Models:
INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX
INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx
INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx Open, Classified |
JAK | None listed |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) Brush, 15mm L, 1.8mm OD
Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic Open, Classified |
JAK | None listed |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endosc Open, Classified |
JAK | None listed |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or end Open, Classified |
JAK | None listed |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomograp Open, Classified |
JAK | None listed |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomograph Open, Classified |
JAK | None listed |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/ Open, Classified |
JAK | None listed |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography an Open, Classified |
JAK | None listed |
| Jul 28, 2023 | Olympus Corporation of the Americas Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga
Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscop Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.