Last synced on 23 September 2022 at 11:05 pm

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150969
510(k) Type
Traditional
Applicant
KARL STORZ ENDOSCOPY AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/8/2016
Days to Decision
270 days
Submission Type
Summary

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150969
510(k) Type
Traditional
Applicant
KARL STORZ ENDOSCOPY AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/8/2016
Days to Decision
270 days
Submission Type
Summary