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FDA 510(k)

VIS-U-ALL II SELF SEAL POUCH

K-Number: K070765 · 2007-10-12

ApplicantSTERIS Corporation
Decision Date2007-10-12
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VIS-U-ALL II SELF SEAL POUCH is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2007-10-12 under 510(k) number K070765. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIS-U-ALL II SELF SEAL POUCH?

VIS-U-ALL II SELF SEAL POUCH is a medical device that received FDA 510(k) clearance on 2007-10-12. The listed applicant is STERIS Corporation. The 510(k) number is K070765.

When did VIS-U-ALL II SELF SEAL POUCH receive FDA 510(k) clearance?

VIS-U-ALL II SELF SEAL POUCH received FDA 510(k) clearance on 2007-10-12, under 510(k) number K070765.

Who is the listed applicant for VIS-U-ALL II SELF SEAL POUCH?

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 VIS-U-ALL II SELF SEAL POUCH?

The FDA product code for VIS-U-ALL II SELF SEAL POUCH is KCT.

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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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