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FDA 510(k)

Surgical Angle Handpiece, Surgical Straight Handpiece

K-Number: K171155 · 2017-11-21

ApplicantNakanishi, Inc.
Decision Date2017-11-21
Product CodeKMW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Surgical Angle Handpiece, Surgical Straight Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K171155. The device is classified under product code KMW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surgical Angle Handpiece, Surgical Straight Handpiece?

Surgical Angle Handpiece, Surgical Straight Handpiece is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Nakanishi, Inc.. The 510(k) number is K171155.

When did Surgical Angle Handpiece, Surgical Straight Handpiece receive FDA 510(k) clearance?

Surgical Angle Handpiece, Surgical Straight Handpiece received FDA 510(k) clearance on 2017-11-21, under 510(k) number K171155.

Who is the listed applicant for Surgical Angle Handpiece, Surgical Straight Handpiece?

The FDA 510(k) record lists Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Angle Handpiece, Surgical Straight Handpiece?

The FDA product code for Surgical Angle Handpiece, Surgical Straight Handpiece is KMW.

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Related Devices (Code: KMW)

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.

K211584Oral Surgery ContraNakanishi, Inc.K162544OsteoMed PINNACLE DriverOsteomed

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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