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FDA 510(k)

NTECH ARTHROSCOPE

K-Number: K980599 · 1998-04-15

ApplicantN-Tech Endoscopy, Inc.
Decision Date1998-04-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NTECH ARTHROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is N-Tech Endoscopy, Inc.. It received FDA 510(k) clearance on 1998-04-15 under 510(k) number K980599. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NTECH ARTHROSCOPE?

NTECH ARTHROSCOPE is a medical device that received FDA 510(k) clearance on 1998-04-15. The listed applicant is N-Tech Endoscopy, Inc.. The 510(k) number is K980599.

When did NTECH ARTHROSCOPE receive FDA 510(k) clearance?

NTECH ARTHROSCOPE received FDA 510(k) clearance on 1998-04-15, under 510(k) number K980599.

Who is the listed applicant for NTECH ARTHROSCOPE?

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

What is the FDA product code for NTECH ARTHROSCOPE?

The FDA product code for NTECH ARTHROSCOPE is GCJ.

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 N-Tech Endoscopy, 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.

K980623N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPEK980592NTECH CYSTOSCOPES

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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