# fda_510k (us_fda)

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

## 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](/companies/quantum-surgical.md)

## Covered models (1)

- [Epione](/models/epione.md)

## Sources (1)

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

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