FDA 510(k)

AMID STAPLER

K-Number: K093253 · 2009-11-12

Decision Date2009-11-12

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AMID STAPLER is the device name listed in this FDA 510(k) record. The listed applicant is Safestitch, LLC. It received FDA 510(k) clearance on 2009-11-12 under 510(k) number K093253. 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 AMID STAPLER?

AMID STAPLER is a medical device that received FDA 510(k) clearance on 2009-11-12. The listed applicant is Safestitch, LLC. The 510(k) number is K093253.

When did AMID STAPLER receive FDA 510(k) clearance?

AMID STAPLER received FDA 510(k) clearance on 2009-11-12, under 510(k) number K093253.

Who is the listed applicant for AMID STAPLER?

The FDA 510(k) record lists Safestitch, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMID STAPLER?

The FDA product code for AMID STAPLER is GDW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.