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FDA 510(k)

BIOPSY M

K-Number: K982049 · 1998-07-14

ApplicantSitco, Inc.
Decision Date1998-07-14
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOPSY M is the device name listed in this FDA 510(k) record. The listed applicant is Sitco, Inc.. It received FDA 510(k) clearance on 1998-07-14 under 510(k) number K982049. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY M?

BIOPSY M is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Sitco, Inc.. The 510(k) number is K982049.

When did BIOPSY M receive FDA 510(k) clearance?

BIOPSY M received FDA 510(k) clearance on 1998-07-14, under 510(k) number K982049.

Who is the listed applicant for BIOPSY M?

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

What is the FDA product code for BIOPSY M?

The FDA product code for BIOPSY M is IZH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sitco, 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.

K990192BIOPSY-DIGITK973856GIOTTO HTK953255NUQUEST NUCLEAR MEDICINE COMPUTER

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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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