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FDA 510(k)

7D Surgical System (10-0001)

K-Number: K260403 · 2026-10-19

Applicant7D Surgical ULC
Decision Date2026-10-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

7D Surgical System (10-0001) is the device name listed in this FDA 510(k) record. The listed applicant is 7D Surgical ULC. It received FDA 510(k) clearance on 2026-10-19 under 510(k) number K260403. 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 (10-0001)?

7D Surgical System (10-0001) is a medical device that received FDA 510(k) clearance on 2026-10-19. The listed applicant is 7D Surgical ULC. The 510(k) number is K260403.

When did 7D Surgical System (10-0001) receive FDA 510(k) clearance?

7D Surgical System (10-0001) received FDA 510(k) clearance on 2026-10-19, under 510(k) number K260403.

Who is the listed applicant for 7D Surgical System (10-0001)?

The FDA 510(k) record lists 7D Surgical ULC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7D Surgical System (10-0001)?

The FDA product code for 7D Surgical System (10-0001) is OLO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing 7D Surgical ULC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242480FLASH EVD System (10-0002)

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K263234TMINI Miniature Robotic SystemTHINK Surgical, Inc.K263154CarboClear® Cervical Navigated InstrumentsCarboFix Orhtopedics , Ltd.K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SEK262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SA

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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