FDA 510(k)

SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW

K-Number: K012224 · 2001-08-22

Decision Date2001-08-22

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW is the device name listed in this FDA 510(k) record. The listed applicant is Ranfac, Corp.. It received FDA 510(k) clearance on 2001-08-22 under 510(k) number K012224. 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 SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW?

SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW is a medical device that received FDA 510(k) clearance on 2001-08-22. The listed applicant is Ranfac, Corp.. The 510(k) number is K012224.

When did SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW receive FDA 510(k) clearance?

SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW received FDA 510(k) clearance on 2001-08-22, under 510(k) number K012224.

Who is the listed applicant for SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW?

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

What is the FDA product code for SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW?

The FDA product code for SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW is KNW.

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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.