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FDA 510(k)

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)

K-Number: K230480 · 2023-04-28

ApplicantTeleflex Medical
Decision Date2023-04-28
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2023-04-28 under approval number K230480. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)?

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) is a medical device that received FDA 510(k) clearance on 2023-04-28. It is manufactured by Teleflex Medical. The 510(k) number is K230480.

When was Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) approved by the FDA?

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) received FDA 510(k) clearance on 2023-04-28, under approval number K230480.

What company makes Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)?

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) is manufactured by Teleflex Medical.

What is the FDA product code for Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)?

The FDA product code for Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) is FZP.

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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.

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