510(k) K910785
K910785 is an FDA 510(k) premarket notification submitted by Accurate Surgical Instruments Co. for the device "TITANIUM CATHETER EXTENDER". The FDA issued a decision of Substantially Equivalent on August 22, 1991. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Accurate Surgical Instruments Co. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 1991
- Date Received
- February 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peritoneal, Long-Term Indwelling
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type