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FDA 510(k)

N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE

K-Number: K980623 · 1998-04-30

ApplicantN-Tech Endoscopy, Inc.
Decision Date1998-04-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE 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 1998-04-30 under 510(k) number K980623. 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 N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE?

N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is N-Tech Endoscopy, Inc.. The 510(k) number is K980623.

When did N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE receive FDA 510(k) clearance?

N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE received FDA 510(k) clearance on 1998-04-30, under 510(k) number K980623.

Who is the listed applicant for N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE?

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 N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE?

The FDA product code for N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE 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.

K980592NTECH CYSTOSCOPESK980599NTECH ARTHROSCOPE

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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