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FDA 510(k)

SPARTA BRONCHIAL BRUSH

K-Number: K781365 · 1978-08-14

ApplicantSparta Instrument Corp.
Decision Date1978-08-14
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SPARTA BRONCHIAL BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Sparta Instrument Corp.. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781365. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPARTA BRONCHIAL BRUSH?

SPARTA BRONCHIAL BRUSH is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Sparta Instrument Corp.. The 510(k) number is K781365.

When did SPARTA BRONCHIAL BRUSH receive FDA 510(k) clearance?

SPARTA BRONCHIAL BRUSH received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781365.

Who is the listed applicant for SPARTA BRONCHIAL BRUSH?

The FDA 510(k) record lists Sparta Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPARTA BRONCHIAL BRUSH?

The FDA product code for SPARTA BRONCHIAL BRUSH is KTI.

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 Sparta Instrument Corp. 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.

K854475GHAJAR INTRAVENTRICULAR CATHETER GUIDEK780258MILK BATH CONCENTRATEK780257MICROSPEARS

Related Devices (Code: KTI)

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.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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