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FDA 510(k)

KEISEI SCALPEL (STERILE AND NON-STERILE)

K-Number: K863213 · 1986-09-02

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

Device Summary

KEISEI SCALPEL (STERILE AND NON-STERILE) 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 K863213. The device is classified under product code GDX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEISEI SCALPEL (STERILE AND NON-STERILE)?

KEISEI SCALPEL (STERILE AND NON-STERILE) 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 K863213.

When did KEISEI SCALPEL (STERILE AND NON-STERILE) receive FDA 510(k) clearance?

KEISEI SCALPEL (STERILE AND NON-STERILE) received FDA 510(k) clearance on 1986-09-02, under 510(k) number K863213.

Who is the listed applicant for KEISEI SCALPEL (STERILE AND NON-STERILE)?

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 SCALPEL (STERILE AND NON-STERILE)?

The FDA product code for KEISEI SCALPEL (STERILE AND NON-STERILE) is GDX.

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.

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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.

K863212KEISEI HANDLES FOR SURGICAL BLADESK863214KEISEI MICRO-BLADES (STERILE AND NON-STERILE)K863211KEISEI SURGICAL BLADES (STERILE & NON-STERILE)

Related Devices (Code: GDX)

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.

K923689SURGISTAR BLADESSurgistar, Inc.K921167ULTRABLADEMicron Technology, Inc.K914086ICAN CYLINDRICAL SPONGESIcn Pharmaceuticals, Inc.K904505CCI CORNEAL SCARIFIERBuckman Co., Inc.K9053801-CUT ACL GRAFT KNIFEDepuy, Inc.K895682VESSEL LOOPSApplied Medical Technologies

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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