510(k) K183335
K183335 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Medline Poly-Cath Red Polymer Urethral Catheter". The FDA issued a decision of Substantially Equivalent on June 12, 2019. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2019
- Date Received
- December 3, 2018
- 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