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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 the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2024-07-05 under 510(k) 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. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K241111.

When did AMT Suture Passer receive FDA 510(k) clearance?

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

Who is the listed applicant for AMT Suture Passer?

The FDA 510(k) record lists Applied Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMT Suture Passer?

The FDA product code for AMT Suture Passer is GCJ.

Other records listing Applied Medical Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 11 devices →

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.