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FDA 510(k)

ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA

K-Number: K934623 · 1993-12-02

ApplicantEndomedix
Decision Date1993-12-02
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Endomedix. It received FDA 510(k) clearance on 1993-12-02 under 510(k) number K934623. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA?

ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA is a medical device that received FDA 510(k) clearance on 1993-12-02. The listed applicant is Endomedix. The 510(k) number is K934623.

When did ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA receive FDA 510(k) clearance?

ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA received FDA 510(k) clearance on 1993-12-02, under 510(k) number K934623.

Who is the listed applicant for ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA?

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

What is the FDA product code for ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA?

The FDA product code for ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA is FET.

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Other records listing Endomedix 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.

K934170ENDOMEDIX Y-ADAPTERK930499GRASPING FORCEPS FLEXIBLE STONE DISLODGERK930349STONE RETRIEVAL BASKETK926004ENDOSCOPE AND ACCOSSORIESK922837S1500 XENON LIGHT SOURCEK922082LAPAROSCOPIC INTRODUCER

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Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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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