510(k) K023358
K023358 is an FDA 510(k) premarket notification submitted by Acmi Corporation for the device "USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8". The FDA issued a decision of Substantially Equivalent on January 3, 2003. The device falls under product code FGB (Ureteroscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Acmi Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2003
- Date Received
- October 7, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ureteroscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).