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FDA 510(k)

REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT

K-Number: K130282 · 2013-05-13

ApplicantRemington Medical, Inc.
Decision Date2013-05-13
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Remington Medical, Inc.. It received FDA 510(k) clearance on 2013-05-13 under 510(k) number K130282. 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 REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT?

REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT is a medical device that received FDA 510(k) clearance on 2013-05-13. The listed applicant is Remington Medical, Inc.. The 510(k) number is K130282.

When did REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT receive FDA 510(k) clearance?

REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT received FDA 510(k) clearance on 2013-05-13, under 510(k) number K130282.

Who is the listed applicant for REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT?

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

What is the FDA product code for REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT?

The FDA product code for REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT is KNW.

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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

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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