7D Surgical System
FDA 510(k) K183276 · 7D Surgical, Inc.
510(k) numberK183276
Submission
- Device name
- 7D Surgical System
- Applicant
- 7D Surgical, Inc.
Toronto, CA - Received
- November 23, 2018
- Decision date
- August 7, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
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|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame)OLO · Special | 05/20/2022SE |
| K210457 | 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm…OLO · Traditional | 06/21/2021SE |
| K210555 | 7D Surgical System - Drill GuideOLO · Special | 03/23/2021SE |
| K201966 | 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical…OLO · Special | 09/03/2020SE |
| K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement ApplicationHAW · Special | 11/27/2019SE |
| K192140 | 7D Surgical SystemOLO · Traditional | 11/05/2019SE |
| K181041 | 7D Surgical System Cranial ApplicationHAW · Traditional | 08/08/2018SE |
| K180352 | 7D Surgical SystemOLO · Special | 05/02/2018SE |
| K162375 | Envision 3D: Image Guidance SystemOLO · Traditional | 12/29/2016SE |
Questions and answers
When was 7D Surgical System cleared by the FDA?
7D Surgical System (K183276) received a 510(k) decision of Substantially Equivalent on August 7, 2019, 257 days after the submission was received.
What is the product code of K183276?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.