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FDA 510(k)

SPOT ENDOSCOPIC MARKER

K-Number: K993951 · 2000-02-18

ApplicantChek-Med Systems
Decision Date2000-02-18
Product CodeNBG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPOT ENDOSCOPIC MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Chek-Med Systems. It received FDA 510(k) clearance on 2000-02-18 under 510(k) number K993951. The device is classified under product code NBG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPOT ENDOSCOPIC MARKER?

SPOT ENDOSCOPIC MARKER is a medical device that received FDA 510(k) clearance on 2000-02-18. The listed applicant is Chek-Med Systems. The 510(k) number is K993951.

When did SPOT ENDOSCOPIC MARKER receive FDA 510(k) clearance?

SPOT ENDOSCOPIC MARKER received FDA 510(k) clearance on 2000-02-18, under 510(k) number K993951.

Who is the listed applicant for SPOT ENDOSCOPIC MARKER?

The FDA 510(k) record lists Chek-Med Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPOT ENDOSCOPIC MARKER?

The FDA product code for SPOT ENDOSCOPIC MARKER is NBG.

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 Chek-Med Systems 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.

K041783POLAR WANDK021387POLAR WAND

Related Devices (Code: NBG)

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.

K042901ENDOMARK STERILE INDIA INKPmt 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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