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FDA 510(k)

ENDOSCOPE AND ACCOSSORIES

K-Number: K926004 · 1993-02-10

ApplicantEndomedix
Decision Date1993-02-10
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE AND ACCOSSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Endomedix. It received FDA 510(k) clearance on 1993-02-10 under 510(k) number K926004. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPE AND ACCOSSORIES?

ENDOSCOPE AND ACCOSSORIES is a medical device that received FDA 510(k) clearance on 1993-02-10. The listed applicant is Endomedix. The 510(k) number is K926004.

When did ENDOSCOPE AND ACCOSSORIES receive FDA 510(k) clearance?

ENDOSCOPE AND ACCOSSORIES received FDA 510(k) clearance on 1993-02-10, under 510(k) number K926004.

Who is the listed applicant for ENDOSCOPE AND ACCOSSORIES?

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 ENDOSCOPE AND ACCOSSORIES?

The FDA product code for ENDOSCOPE AND ACCOSSORIES is FGB.

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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-ADAPTERK934623ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERAK930499GRASPING FORCEPS FLEXIBLE STONE DISLODGERK930349STONE RETRIEVAL BASKETK922837S1500 XENON LIGHT SOURCEK922082LAPAROSCOPIC INTRODUCER

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Related Devices (Code: FGB)

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.

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific CorporationK262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical 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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