Volnewmer— 510(k) K253504
Substantially EquivalentClassys, Inc.
FDA 510(k) clearance K253504 for Volnewmer, Substantially Equivalent on 2026-07-13. Applicant: Classys, Inc.. Device class: 2.
Summary
Classys's Volnewmer is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record gives no model numbers or specs.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and it was a Traditional 510(k).
Classys filed from Seoul, South Korea. Review took 255 calendar days (October 31, 2025 to July 13, 2026).
Clearance details
- Applicant
- Classys, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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More clearances from Classys, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.