SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE— 510(k) K122106

Clearance details

Applicant

Veran Medical Technologies, Inc.

Product code

Code JAK

Device class

Class 2

Regulation

21 CFR 892.1750

Advisory panel

Radiology

Date received

2012-07-17

Decision date

2012-12-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St. Louis, MO, US

• K253836 — FCT iStream Phase 22026-09-04
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• K253770 — CardIQ Suite2026-07-21
• K253560 — Enhanced Boundary for PCCT2026-06-24
• K253026 — Respiratory Gating for Scanners (2.1)2026-06-04

• K202346 — SPiN Vision Video Bronchoscope System2021-02-19
• K170023 — SPiN Thoracic Navigation System2017-05-15
• K093995 — IG 4 IMAGE GUIDED SYSTEM2010-01-27
• K091934 — IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-03002009-12-02
• K093146 — IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-02002009-11-30

Death

27

Injury

571

Malfunction

779

Total

1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2659-2023 — 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 Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-2400 SPiN Drive System SYS-2230 ig4 System V2, 230V, 50Hz SYS-2000 ig4 Image Guides System SYS-1500 SPiN View" System SYS-1000 ig4 Image Guides System SYS-0220 ig4 System, 220V, 50Hz SYS-0185 SPiN Planning Laptop Workstation SYS-0128 Planning Workstation w/Monitor SYS-0002 ig4 System INS-7150 SPiN Vision Scope AdapterClass II·Ongoing·Olympus Corporation of the Americas·20230810
• Z-2661-2023 — 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 Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)Class II·Ongoing·Olympus Corporation of the Americas·20230810
• Z-2662-2023 — 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, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx INS-5323 Sliding stopper INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx"Class II·Ongoing·Olympus Corporation of the Americas·20230810
• Z-2663-2023 — 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-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354 INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint" INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point INS-5017 17ga x 155mm Tip Tracked Bx Needle INS-5016 17ga x 155mm Tip Tracked Bx NeedleClass II·Ongoing·Olympus Corporation of the Americas·20230810
• Z-2664-2023 — 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 INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm INS-0050 vPad Patient Tracker, 5/Bx INS-0048 vPad Connector CableClass II·Ongoing·Olympus Corporation of the Americas·20230810
• Z-2262-2023 — 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 bronchoscopy are currently used for visualizing Model: INS-0352Class II·Ongoing·Olympus Corporation of the Americas·20230515
• Z-2263-2023 — 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 endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0362Class II·Ongoing·Olympus Corporation of the Americas·20230515
• Z-2264-2023 — 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 endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0372Class II·Ongoing·Olympus Corporation of the Americas·20230515
• Z-2265-2023 — 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 tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0382Class II·Ongoing·Olympus Corporation of the Americas·20230515
• Z-2266-2023 — 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 tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-0392Class II·Ongoing·Olympus Corporation of the Americas·20230515
• Z-2267-2023 — 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/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-5300Class II·Ongoing·Olympus Corporation of the Americas·20230515
• Z-2268-2023 — 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 and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-5410Class II·Ongoing·Olympus Corporation of the Americas·20230515
• Z-2269-2023 — 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 endoscopic brINS-0362onchoscopy are currently used for visualizing Model: INS-5450Class II·Ongoing·Olympus Corporation of the Americas·20230515

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122106.