Regulatory filing

fda_510k (us_fda)

FDA 510(k) clearance for Epione robot for cancer treatment (abdominal ablation). CE Mark for abdomen, chest, and musculoskeletal.

fda 510k · cleared · decided 2022-03-22

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing date: 2022-03-22
Decision date: 2022-03-22
Verification posture: verified
Cap-flag notes: FDA for abdominal. CE Mark broader scope.

Applicant

Quantum Surgical

Covered models (1)

Epione

Sources (1)

https://www.quantumsurgical.com/news/quantum-surgical-receives-fda-510k-clearance-for-the-epione-robot-designed-for-cancer-treatment

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Identity

2b2c3dfa-2849-4673-bd6d-b6470de16c14