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FDA 510(k)

Equipment Pouch

K-Number: K172578 · 2017-12-07

Decision Date2017-12-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Equipment Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K172578. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Equipment Pouch?

Equipment Pouch is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. The 510(k) number is K172578.

When did Equipment Pouch receive FDA 510(k) clearance?

Equipment Pouch received FDA 510(k) clearance on 2017-12-07, under 510(k) number K172578.

Who is the listed applicant for Equipment Pouch?

The FDA 510(k) record lists Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Equipment Pouch?

The FDA product code for Equipment Pouch is GCJ.

Other records listing Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd as applicant

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.

Related Devices (Code: GCJ)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.