Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
FDA 510(k) clearance K202112 · decided 2021-02-21
Clearance details
- K-number
- K202112
- Device name
- Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
- Applicant
- Storz Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2020-07-30
- Decision date
- 2021-02-21
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- PZL
- Device class
- 2
- Regulation number
- 878.4685
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tagerwilen, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Storz Medical Duolith SD1 Shock Wave Therapy Device (P080028/S001) | Storz Medical AG | 2020-02-05 |
| STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY (P080028) | Storz Medical AG | 2016-01-08 |