510(k) K200134
K200134 is an FDA 510(k) premarket notification submitted by Hangzhou Jimushi Meditech Co., Ltd. for the device "Jimushi Sterile Urethral Catheter for single use". The FDA issued a decision of Substantially Equivalent on June 1, 2020. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hangzhou Jimushi Meditech Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 2020
- Date Received
- January 21, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urethral
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type