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FDA 510(k)

SterileRight sterilization pouch and roll

K-Number: K212338 · 2021-11-01

ApplicantSterileright Packaging Mfg., Inc.
Decision Date2021-11-01
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SterileRight sterilization pouch and roll is a medical device manufactured by Sterileright Packaging Mfg., Inc.. It received FDA 510(k) clearance on 2021-11-01 under approval number K212338. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SterileRight sterilization pouch and roll?

SterileRight sterilization pouch and roll is a medical device that received FDA 510(k) clearance on 2021-11-01. It is manufactured by Sterileright Packaging Mfg., Inc.. The 510(k) number is K212338.

When was SterileRight sterilization pouch and roll approved by the FDA?

SterileRight sterilization pouch and roll received FDA 510(k) clearance on 2021-11-01, under approval number K212338.

What company makes SterileRight sterilization pouch and roll?

SterileRight sterilization pouch and roll is manufactured by Sterileright Packaging Mfg., Inc..

What is the FDA product code for SterileRight sterilization pouch and roll?

The FDA product code for SterileRight sterilization pouch and roll is FRG.

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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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