510(k) K260394
K260394 is an FDA 510(k) premarket notification submitted by Hangzhou Jimushi Meditech Co., Ltd. for the device "Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)". The FDA issued a decision of Substantially Equivalent on June 24, 2026. The device falls under product code EZD (Catheter, Straight), 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 24, 2026
- Date Received
- February 6, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type