510(k) K152771
K152771 is an FDA 510(k) premarket notification submitted by Sumitomo Bakelite Co., Ltd. for the device "SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long". The FDA issued a decision of Substantially Equivalent on Jun 17, 2016. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Sumitomo Bakelite Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 17, 2016
- Date Received
- Sep 25, 2015
- 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
- 510(k)