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FDA 510(k)

EXCISOR BIOPTOME, MODEL 01-0004

K-Number: K032847 · 2003-09-26

ApplicantAcueity, Inc.
Decision Date2003-09-26
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXCISOR BIOPTOME, MODEL 01-0004 is the device name listed in this FDA 510(k) record. The listed applicant is Acueity, Inc.. It received FDA 510(k) clearance on 2003-09-26 under 510(k) number K032847. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCISOR BIOPTOME, MODEL 01-0004?

EXCISOR BIOPTOME, MODEL 01-0004 is a medical device that received FDA 510(k) clearance on 2003-09-26. The listed applicant is Acueity, Inc.. The 510(k) number is K032847.

When did EXCISOR BIOPTOME, MODEL 01-0004 receive FDA 510(k) clearance?

EXCISOR BIOPTOME, MODEL 01-0004 received FDA 510(k) clearance on 2003-09-26, under 510(k) number K032847.

Who is the listed applicant for EXCISOR BIOPTOME, MODEL 01-0004?

The FDA 510(k) record lists Acueity, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXCISOR BIOPTOME, MODEL 01-0004?

The FDA product code for EXCISOR BIOPTOME, MODEL 01-0004 is KNW.

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Other records listing Acueity, Inc. 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.

K040949VIADUCT MINISCOPE AND ACCESSORIESK032430ACUEITY MEDICAL LIGHT SOURCEK011189VIADUCT MICROENDOSCOPE AND ACCESSORIES

Related Devices (Code: KNW)

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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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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