510(k) K242888
K242888 is an FDA 510(k) premarket notification submitted by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. for the device "Electrohydraulic Lithotriptor (TCS-B3-II)". The FDA issued a decision of Substantially Equivalent on March 21, 2025. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2025
- Date Received
- September 23, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Electro-Hydraulic
- Device Class
- Class II
- Regulation Number
- 876.4480
- Review Panel
- GU
- Submission Type