Electroporation System (N3000)
FDA 510(k) clearance K240376 · decided 2024-10-04
Clearance details
- K-number
- K240376
- Device name
- Electroporation System (N3000)
- Applicant
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-07
- Decision date
- 2024-10-04
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- OAB
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cixi, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Surgnova Healthcare Technologies (Zhejiang) Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.