Search Results
Found 1 results
510(k) Data Aggregation
K Number
K153202Device Name
iMESH Tacker
Manufacturer
Date Cleared
2016-03-24
(141 days)
Product Code
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
THD LAP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
Device Description
Like the original iMESH Tacker, the modified iMESH Tacker is a sterile, single use device for the fixation of prosthetic material, such as a hernia mesh, onto soft tissue. The applicator features an articulating tip. The absorbable tack is made of synthetic polyester derived from a lactic acid and glycolic acid copolymer (PLA/PGA). The modified device's implantable Tack is violet colored. The Applicator is pre-loaded with up to 30 Tacks.
The iMESH Tacker is comprised of 3 parts:
- An in-line handle,
- A shaft with an articulating tip
- The bio-absorbable Tacks
The modified iMESH Tacker is identical to the original iMESH Tacker with the exception of a change in the color of the tacks to violet, several minor internal changes and slight changes to packaging and certain components.
Ask a Question
Ask a specific question about this device
Page 1 of 1