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FDA 510(k), K142791, Spectra Soft Tissue Biopsy Needles
FDA 510(k), K142791, Spectra Soft Tissue Biopsy Needles
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510(K) Number: K142791
Device Name: Spectra Soft Tissue Biopsy Needles
Manufacturer: Agustin Turriza
Device Classification Name: Instrument, Biopsy
Regulation Number: KNW
Classification Product Code: KXA
Date Received: 09/26/2014
Decision Date: 01/21/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Spectra Soft Tissue Biopsy Needles
Manufacturer: Agustin Turriza
Device Classification Name: Instrument, Biopsy
Regulation Number: KNW
Classification Product Code: KXA
Date Received: 09/26/2014
Decision Date: 01/21/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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