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FDA 510(k)

BASICS ENDOSCOPY SYSTEM

K-Number: K940911 · 1994-05-16

ApplicantCox Medical Ent., Inc.
Decision Date1994-05-16
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BASICS ENDOSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cox Medical Ent., Inc.. It received FDA 510(k) clearance on 1994-05-16 under 510(k) number K940911. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BASICS ENDOSCOPY SYSTEM?

BASICS ENDOSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-05-16. The listed applicant is Cox Medical Ent., Inc.. The 510(k) number is K940911.

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

BASICS ENDOSCOPY SYSTEM received FDA 510(k) clearance on 1994-05-16, under 510(k) number K940911.

Who is the listed applicant for BASICS ENDOSCOPY SYSTEM?

The FDA 510(k) record lists Cox Medical Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BASICS ENDOSCOPY SYSTEM?

The FDA product code for BASICS ENDOSCOPY SYSTEM is KGE.

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Other records listing Cox Medical Ent., 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.

K950689UCBK946360MODULAR BIOPSY FORCEPK941464BASICS ENDOSCOPY SYSTEMK932790THERMAL OPTIONK935250ACCU-PATHK924655COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)

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Related Devices (Code: KGE)

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.

K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems CorporationK242857ClearHemograsperFinemedix Co., Ltd.K231721Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd.K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm CorporationK210406Bipolar Coagulation ForecepsHangzhou AGS MedTech 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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