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)

AMT Suture Passer

K-Number: K241111 · 2024-07-05

Decision Date2024-07-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMT Suture Passer is a medical device manufactured by Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-07-05 under approval number K241111. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMT Suture Passer?

AMT Suture Passer is a medical device that received FDA 510(k) clearance on 2024-07-05. It is manufactured by Applied Medical Technology, Inc.. The 510(k) number is K241111.

When was AMT Suture Passer approved by the FDA?

AMT Suture Passer received FDA 510(k) clearance on 2024-07-05, under approval number K241111.

What company makes AMT Suture Passer?

AMT Suture Passer is manufactured by Applied Medical Technology, Inc..

What is the FDA product code for AMT Suture Passer?

The FDA product code for AMT Suture Passer is GCJ.

Other Devices by Applied Medical Technology, Inc.

View all 11 devices →

Related Devices (Code: GCJ)

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.