510(k) K841224
K841224 is an FDA 510(k) premarket notification submitted by Gil-Med Industries C/O Kegan & Kegan, Ltd. for the device "URO-MALE INCONTINENCE CATHETER". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Gil-Med Industries C/O Kegan & Kegan, Ltd. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1984
- Date Received
- Mar 22, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Collector, Urine, (And Accessories) For Indwelling Catheter
- Device Class
- Class II
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type
- 510(k) Exempt