Last synced on 25 January 2026 at 3:41 am

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213831
510(k) Type
Special
Applicant
Gyrus Acmi, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/2022
Days to Decision
27 days
Submission Type
Summary

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213831
510(k) Type
Special
Applicant
Gyrus Acmi, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/2022
Days to Decision
27 days
Submission Type
Summary