CARTO ENT System
FDA 510(k) K161701 · Biosense Webster
510(k) numberK161701
Submission
- Device name
- CARTO ENT System
- Applicant
- Biosense Webster
Diamond Bar, CA, US - Received
- June 20, 2016
- Decision date
- October 24, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGW – Ear, Nose, And Throat Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Other 510(k)s with product code PGW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated…PGW · Traditional | Medtronic Xomed, Inc. | 09/04/2026SE |
| K261540 | Cube 4D Navigation System, VirtuEye ProPGW · Special | Fiagon GmbH | 06/02/2026SE |
| K253395 | Stealth AXiS ENT clinical applicationPGW · Traditional | Medtronic Navigation, Inc. | 03/16/2026SE |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC)PGW · Traditional | Claronav | 06/20/2025SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | Acclarent, Inc. | 07/21/2023SE |
| K223734 | ENT EmPGW · Traditional | Brainlab AG | 04/27/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | Acclarent, Inc. | 07/20/2022SE |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…PGW · Traditional | Stryker Corporation | 07/12/2022SE |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW · Traditional | Fiagon GmbH | 07/19/2021SE |
| K202609 | Instrument Clamps ElectromagneticPGW · Special | Stryker Corporation | 10/09/2020SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K252972 | CARTO 3 EP Navigation System V8.4DQK · Traditional | 02/20/2026SE |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU PlusDQK · Special | 01/18/2026SE |
| K252302 | CARTO 3 EP Navigation System V8.1DQK · Special | 08/22/2025SE |
| K241540 | NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound CatheterOBJ · Special | 06/28/2024SE |
| K240050 | SOUNDSTAR CRYSTAL Ultrasound CatheterOBJ · Special | 06/12/2024SE |
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK · Traditional | 09/07/2023SE |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)DYB · Special | 07/10/2023SE |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…MTD · Special | 07/10/2023SE |
| K230253 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Special | 03/02/2023SE |
| K223766 | NUVISION NAV Ultrasound CatheterOBJ · Traditional | 02/16/2023SE |
Questions and answers
When was CARTO ENT System cleared by the FDA?
CARTO ENT System (K161701) received a 510(k) decision of Substantially Equivalent on October 24, 2016, 126 days after the submission was received.
What is the product code of K161701?
The FDA product code is PGW – Ear, Nose, And Throat Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.