Last synced on 12 April 2024 at 11:04 pm

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200318
510(k) Type
Traditional
Applicant
Karl Storz Endoscopy-America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/22/2020
Days to Decision
258 days
Submission Type
Summary

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200318
510(k) Type
Traditional
Applicant
Karl Storz Endoscopy-America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/22/2020
Days to Decision
258 days
Submission Type
Summary