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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 the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2023-04-28 under 510(k) 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. The listed applicant is Teleflex Medical. The 510(k) number is K230480.

When did Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) receive FDA 510(k) clearance?

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

Who is the listed applicant for Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)?

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

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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Related Devices (Code: FZP)

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.

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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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