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FDA 510(k)

KEISEI MICRO-BLADES (STERILE AND NON-STERILE)

K-Number: K863214 · 1986-09-02

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

Device Summary

KEISEI MICRO-BLADES (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 K863214. The device is classified under product code GES. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEISEI MICRO-BLADES (STERILE AND NON-STERILE)?

KEISEI MICRO-BLADES (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 K863214.

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

KEISEI MICRO-BLADES (STERILE AND NON-STERILE) received FDA 510(k) clearance on 1986-09-02, under 510(k) number K863214.

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

The FDA product code for KEISEI MICRO-BLADES (STERILE AND NON-STERILE) is GES.

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 BLADESK863213KEISEI SCALPEL (STERILE AND NON-STERILE)K863211KEISEI SURGICAL BLADES (STERILE & NON-STERILE)

Related Devices (Code: GES)

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.

K032242PERSONNA PLUS SAFETY SCALPEL SYSTEMOmi Manufacturing Pty., Ltd.K932998EASY-ONDevon Industries, Inc.K923170LOS ALAMOS RETRACTABLE KNIFEInnovative Surgical Technology, Inc.K915119SCALPEL BLADE REMOVER (BLADEGARD)Intergrated Visual, Inc.K911913PRECISION GLIDE - ENHANCED SURGICAL BLADEBd Becton Dickinson Vacutainer Systems PreanalyticK900266STERILE CARBON STEEL SURGICAL BLADERahn Laboratories

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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