Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STANDARD ENDOSCOPE

K-Number: K972056 · 1997-07-30

ApplicantLaser-Optik-Systeme GmbH & Co. KG
Decision Date1997-07-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STANDARD ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Laser-Optik-Systeme GmbH & Co. KG. It received FDA 510(k) clearance on 1997-07-30 under 510(k) number K972056. 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 STANDARD ENDOSCOPE?

STANDARD ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Laser-Optik-Systeme GmbH & Co. KG. The 510(k) number is K972056.

When did STANDARD ENDOSCOPE receive FDA 510(k) clearance?

STANDARD ENDOSCOPE received FDA 510(k) clearance on 1997-07-30, under 510(k) number K972056.

Who is the listed applicant for STANDARD ENDOSCOPE?

The FDA 510(k) record lists Laser-Optik-Systeme GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STANDARD ENDOSCOPE?

The FDA product code for STANDARD ENDOSCOPE 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 Laser-Optik-Systeme GmbH & Co. KG 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.

K992540XENON LIGHT SOURCE PES 1K950712PORTABLE ENDOSCOPY SYSTEMK953419LOS 3D VISION 100K952028COLD LIGHT SOURCE LOS XL-A 100K951829COLD LIGHT SOURCE LOS 150K930965LOS 3D VISION 100

View all 7 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑