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FDA 510(k)

ESOPHAGEAL OVERTUBE

K-Number: K890629 · 1989-05-31

ApplicantGastrotech, Inc.
Decision Date1989-05-31
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL OVERTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Gastrotech, Inc.. It received FDA 510(k) clearance on 1989-05-31 under 510(k) number K890629. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESOPHAGEAL OVERTUBE?

ESOPHAGEAL OVERTUBE is a medical device that received FDA 510(k) clearance on 1989-05-31. The listed applicant is Gastrotech, Inc.. The 510(k) number is K890629.

When did ESOPHAGEAL OVERTUBE receive FDA 510(k) clearance?

ESOPHAGEAL OVERTUBE received FDA 510(k) clearance on 1989-05-31, under 510(k) number K890629.

Who is the listed applicant for ESOPHAGEAL OVERTUBE?

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

What is the FDA product code for ESOPHAGEAL OVERTUBE?

The FDA product code for ESOPHAGEAL OVERTUBE is FED.

Related Clinical Trials

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Other records listing Gastrotech, 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.

K890658SYRINGE INJECTION GUN DELIVERY KITSK883351PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBEK883336GASTROSTOMY FEEDING TUBEK862853SYRINGE INJECTION GUN

Related Devices (Code: FED)

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.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific CorporationK260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

Official Source

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

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