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FDA 510(k)

7D Surgical System - Percutaneous Application (7D Flash Frame)

K-Number: K220522 · 2022-05-20

Applicant7D Surgical
Decision Date2022-05-20
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

7D Surgical System - Percutaneous Application (7D Flash Frame) is a medical device manufactured by 7D Surgical. It received FDA 510(k) clearance on 2022-05-20 under approval number K220522. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7D Surgical System - Percutaneous Application (7D Flash Frame)?

7D Surgical System - Percutaneous Application (7D Flash Frame) is a medical device that received FDA 510(k) clearance on 2022-05-20. It is manufactured by 7D Surgical. The 510(k) number is K220522.

When was 7D Surgical System - Percutaneous Application (7D Flash Frame) approved by the FDA?

7D Surgical System - Percutaneous Application (7D Flash Frame) received FDA 510(k) clearance on 2022-05-20, under approval number K220522.

What company makes 7D Surgical System - Percutaneous Application (7D Flash Frame)?

7D Surgical System - Percutaneous Application (7D Flash Frame) is manufactured by 7D Surgical.

What is the FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame)?

The FDA product code for 7D Surgical System - Percutaneous Application (7D Flash Frame) is OLO.

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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)

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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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