510(k) K915408
K915408 is an FDA 510(k) premarket notification submitted by Medical Devices, Inc. for the device "BIPOLAR ENDOSTASIS PROBE, BEST (TM)". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Medical Devices, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1992
- Date Received
- December 2, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type