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FDA 510(k)

Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device

K-Number: K180689 · 2018-04-12

ApplicantSTERIS Corporation
Decision Date2018-04-12
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2018-04-12 under 510(k) number K180689. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device?

Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device is a medical device that received FDA 510(k) clearance on 2018-04-12. The listed applicant is STERIS Corporation. The 510(k) number is K180689.

When did Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device receive FDA 510(k) clearance?

Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device received FDA 510(k) clearance on 2018-04-12, under 510(k) number K180689.

Who is the listed applicant for Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device?

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

What is the FDA product code for Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device?

The FDA product code for Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device is PKL.

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Related Devices (Code: PKL)

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Official Source

View on FDA Database →

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