510(k) K200318
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece by
KARL STORZ Endoscopy-America, Inc.
— Product Code ERL
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2020
- Date Received
- February 7, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device Class
- Class II
- Regulation Number
- 874.4250
- Review Panel
- EN
- Submission Type