Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

iMESH Tacker

K-Number: K153202 · 2016-03-24

ApplicantThd Lap
Decision Date2016-03-24
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

iMESH Tacker is a medical device manufactured by Thd Lap. It received FDA 510(k) clearance on 2016-03-24 under approval number K153202. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iMESH Tacker?

iMESH Tacker is a medical device that received FDA 510(k) clearance on 2016-03-24. It is manufactured by Thd Lap. The 510(k) number is K153202.

When was iMESH Tacker approved by the FDA?

iMESH Tacker received FDA 510(k) clearance on 2016-03-24, under approval number K153202.

What company makes iMESH Tacker?

iMESH Tacker is manufactured by Thd Lap.

What is the FDA product code for iMESH Tacker?

The FDA product code for iMESH Tacker is GDW.

Related Devices (Code: GDW)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.