Last synced on 10 January 2025 at 11:05 pm

ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201066
510(k) Type
Traditional
Applicant
Ethicon Endo-Surgery, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/22/2021
Days to Decision
275 days
Submission Type
Summary

ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201066
510(k) Type
Traditional
Applicant
Ethicon Endo-Surgery, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/22/2021
Days to Decision
275 days
Submission Type
Summary