Last synced on 30 September 2022 at 11:05 pm

Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201756
510(k) Type
Traditional
Applicant
Stryker Sustainability Solutions
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/2020
Days to Decision
88 days
Submission Type
Summary

Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201756
510(k) Type
Traditional
Applicant
Stryker Sustainability Solutions
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/2020
Days to Decision
88 days
Submission Type
Summary