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)

PORTABLE ENDOSCOPY SYSTEM

K-Number: K950712 · 1996-05-14

ApplicantLaser-Optik-Systeme GmbH & Co. KG
Decision Date1996-05-14
Product CodeGCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PORTABLE ENDOSCOPY SYSTEM 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 1996-05-14 under 510(k) number K950712. The device is classified under product code GCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE ENDOSCOPY SYSTEM?

PORTABLE ENDOSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-05-14. The listed applicant is Laser-Optik-Systeme GmbH & Co. KG. The 510(k) number is K950712.

When did PORTABLE ENDOSCOPY SYSTEM receive FDA 510(k) clearance?

PORTABLE ENDOSCOPY SYSTEM received FDA 510(k) clearance on 1996-05-14, under 510(k) number K950712.

Who is the listed applicant for PORTABLE ENDOSCOPY SYSTEM?

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 PORTABLE ENDOSCOPY SYSTEM?

The FDA product code for PORTABLE ENDOSCOPY SYSTEM is GCM.

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 1K972056STANDARD ENDOSCOPEK953419LOS 3D VISION 100K952028COLD LIGHT SOURCE LOS XL-A 100K951829COLD LIGHT SOURCE LOS 150K930965LOS 3D VISION 100

View all 7 devices →

Related Devices (Code: GCM)

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.

K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MMRichard Wolf Medical Instruments CorporationK083840MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPEMsi Medserv International Deutschland GmbHK001217INSIDE VIEWMonadnock Optics, Inc.K993103ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREESRichard Wolf Medical Instruments Corp.K993445OMNISONIC ENDOSCOPIC DEFLECTOROmnisonics Medical TechnologiesK962393KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATIONKARL STORZ Endoscopy-America, 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.

↑