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FDA 510(k)

Sterile Endoscope Biopsy Sampling Needle

K-Number: K171956 · 2017-12-12

ApplicantChangzhou Detain Medical Devices Co., Ltd.
Decision Date2017-12-12
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Sterile Endoscope Biopsy Sampling Needle is a medical device manufactured by Changzhou Detain Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2017-12-12 under approval number K171956. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Endoscope Biopsy Sampling Needle?

Sterile Endoscope Biopsy Sampling Needle is a medical device that received FDA 510(k) clearance on 2017-12-12. It is manufactured by Changzhou Detain Medical Devices Co., Ltd.. The 510(k) number is K171956.

When was Sterile Endoscope Biopsy Sampling Needle approved by the FDA?

Sterile Endoscope Biopsy Sampling Needle received FDA 510(k) clearance on 2017-12-12, under approval number K171956.

What company makes Sterile Endoscope Biopsy Sampling Needle?

Sterile Endoscope Biopsy Sampling Needle is manufactured by Changzhou Detain Medical Devices Co., Ltd..

What is the FDA product code for Sterile Endoscope Biopsy Sampling Needle?

The FDA product code for Sterile Endoscope Biopsy Sampling Needle is FCG.

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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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