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FDA 510(k)

KEISEI HANDLES FOR SURGICAL BLADES

K-Number: K863212 · 1986-09-02

ApplicantKeisei Medical Industrial Co., Ltd.
Decision Date1986-09-02
Product CodeGDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KEISEI HANDLES FOR SURGICAL BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Keisei Medical Industrial Co., Ltd.. It received FDA 510(k) clearance on 1986-09-02 under 510(k) number K863212. The device is classified under product code GDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEISEI HANDLES FOR SURGICAL BLADES?

KEISEI HANDLES FOR SURGICAL BLADES is a medical device that received FDA 510(k) clearance on 1986-09-02. The listed applicant is Keisei Medical Industrial Co., Ltd.. The 510(k) number is K863212.

When did KEISEI HANDLES FOR SURGICAL BLADES receive FDA 510(k) clearance?

KEISEI HANDLES FOR SURGICAL BLADES received FDA 510(k) clearance on 1986-09-02, under 510(k) number K863212.

Who is the listed applicant for KEISEI HANDLES FOR SURGICAL BLADES?

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

What is the FDA product code for KEISEI HANDLES FOR SURGICAL BLADES?

The FDA product code for KEISEI HANDLES FOR SURGICAL BLADES is GDZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Keisei Medical Industrial 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.

K863213KEISEI SCALPEL (STERILE AND NON-STERILE)K863214KEISEI MICRO-BLADES (STERILE AND NON-STERILE)K863211KEISEI SURGICAL BLADES (STERILE & NON-STERILE)

Related Devices (Code: GDZ)

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.

K091462SPECTRA MEDICAL SAFETY SCAPELSpectra, Inc.K890242SCALPEL HANDLEKinetic Medical ProductsK884512BEAVER(R) HANDLEBd Becton Dickinson Vacutainer Systems PreanalyticK863951P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLEPrecision Surgical Industries, Inc.K863808THE S. CORDERO STYLUSS. Cordero Co.K854858SCALPEL HANDLEMedelec Intl. Corp.

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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