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FDA 510(k)

7D Surgical System Cranial Application

K-Number: K181041 · 2018-08-08

Applicant7D Surgical, Inc.
Decision Date2018-08-08
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

7D Surgical System Cranial Application is a medical device manufactured by 7D Surgical, Inc.. It received FDA 510(k) clearance on 2018-08-08 under approval number K181041. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7D Surgical System Cranial Application?

7D Surgical System Cranial Application is a medical device that received FDA 510(k) clearance on 2018-08-08. It is manufactured by 7D Surgical, Inc.. The 510(k) number is K181041.

When was 7D Surgical System Cranial Application approved by the FDA?

7D Surgical System Cranial Application received FDA 510(k) clearance on 2018-08-08, under approval number K181041.

What company makes 7D Surgical System Cranial Application?

7D Surgical System Cranial Application is manufactured by 7D Surgical, Inc..

What is the FDA product code for 7D Surgical System Cranial Application?

The FDA product code for 7D Surgical System Cranial Application is HAW.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025)

Other Devices by 7D Surgical, Inc.

K162375Envision 3D: Image Guidance System K1803527D Surgical System K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application K1921407D Surgical System K1832767D Surgical System K2019667D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array

View all 9 devices →

Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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