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FDA 510(k)

NEOPROBE PORTABLE RADIOISOTOPE DETECTOR

K-Number: K864263 · 1986-12-29

ApplicantNeoprobe Corp.
Decision Date1986-12-29
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEOPROBE PORTABLE RADIOISOTOPE DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Neoprobe Corp.. It received FDA 510(k) clearance on 1986-12-29 under 510(k) number K864263. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOPROBE PORTABLE RADIOISOTOPE DETECTOR?

NEOPROBE PORTABLE RADIOISOTOPE DETECTOR is a medical device that received FDA 510(k) clearance on 1986-12-29. The listed applicant is Neoprobe Corp.. The 510(k) number is K864263.

When did NEOPROBE PORTABLE RADIOISOTOPE DETECTOR receive FDA 510(k) clearance?

NEOPROBE PORTABLE RADIOISOTOPE DETECTOR received FDA 510(k) clearance on 1986-12-29, under 510(k) number K864263.

Who is the listed applicant for NEOPROBE PORTABLE RADIOISOTOPE DETECTOR?

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

What is the FDA product code for NEOPROBE PORTABLE RADIOISOTOPE DETECTOR?

The FDA product code for NEOPROBE PORTABLE RADIOISOTOPE DETECTOR is IZD.

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 Neoprobe Corp. 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.

K050088QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZERK971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESK962319NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIESK942580NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESK915279NEOPROBE PORTABLE RADIOSCOPE DETECTOR

Related Devices (Code: IZD)

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.

K123917DECLIPSESPECT VIEWERSurgiceye GmbHK101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbHK013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments GmhbK983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.

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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