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FDA 510(k)

Implanter incl. Accessories

K-Number: K211358 · 2022-11-21

ApplicantGuilin Woodpecker Medical Instrument Co., Ltd.
Decision Date2022-11-21
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Implanter incl. Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K211358. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Implanter incl. Accessories?

Implanter incl. Accessories is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K211358.

When did Implanter incl. Accessories receive FDA 510(k) clearance?

Implanter incl. Accessories received FDA 510(k) clearance on 2022-11-21, under 510(k) number K211358.

Who is the listed applicant for Implanter incl. Accessories?

The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implanter incl. Accessories?

The FDA product code for Implanter incl. Accessories is EBW.

Other records listing Guilin Woodpecker Medical Instrument Co., Ltd. as applicant

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Related Devices (Code: EBW)

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.

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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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