510(k) K211436
K211436 is an FDA 510(k) premarket notification submitted by Hollister Incorporated for the device "Intermittent Catheter (Not Finalized)". The FDA issued a decision of Substantially Equivalent on January 27, 2022. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Hollister Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2022
- Date Received
- May 10, 2021
- 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