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FDA 510(k)

PRIMADO2 TOTAL SURGICAL SYSTEM

K-Number: K132264 · 2013-12-17

ApplicantNakanishi, Inc.
Decision Date2013-12-17
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PRIMADO2 TOTAL SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2013-12-17 under 510(k) number K132264. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMADO2 TOTAL SURGICAL SYSTEM?

PRIMADO2 TOTAL SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-17. The listed applicant is Nakanishi, Inc.. The 510(k) number is K132264.

When did PRIMADO2 TOTAL SURGICAL SYSTEM receive FDA 510(k) clearance?

PRIMADO2 TOTAL SURGICAL SYSTEM received FDA 510(k) clearance on 2013-12-17, under 510(k) number K132264.

Who is the listed applicant for PRIMADO2 TOTAL SURGICAL SYSTEM?

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 PRIMADO2 TOTAL SURGICAL SYSTEM?

The FDA product code for PRIMADO2 TOTAL SURGICAL SYSTEM is HBC.

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Related Devices (Code: HBC)

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.

K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd.K233153Traus SSG10 Surgical SystemSaeshin Precision Co., Ltd.K232938Traus SSG30 Surgical SystemSaeshin Precision Co., Ltd.K213697ORiGO SystemBien-Air Surgery SAK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc.K193630hekaDrillZethon, Ltd.

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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