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FDA 510(k)

MEDOVATIONS ESOPHAGEAL DILATOR

K-Number: K002363 · 2000-11-01

ApplicantMedovations, Inc.
Decision Date2000-11-01
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDOVATIONS ESOPHAGEAL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medovations, Inc.. It received FDA 510(k) clearance on 2000-11-01 under 510(k) number K002363. The device is classified under product code KNQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDOVATIONS ESOPHAGEAL DILATOR?

MEDOVATIONS ESOPHAGEAL DILATOR is a medical device that received FDA 510(k) clearance on 2000-11-01. The listed applicant is Medovations, Inc.. The 510(k) number is K002363.

When did MEDOVATIONS ESOPHAGEAL DILATOR receive FDA 510(k) clearance?

MEDOVATIONS ESOPHAGEAL DILATOR received FDA 510(k) clearance on 2000-11-01, under 510(k) number K002363.

Who is the listed applicant for MEDOVATIONS ESOPHAGEAL DILATOR?

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

What is the FDA product code for MEDOVATIONS ESOPHAGEAL DILATOR?

The FDA product code for MEDOVATIONS ESOPHAGEAL DILATOR is KNQ.

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Other records listing Medovations, 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.

K972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)K924646OVER THE GUIDEWIRE DILATATION SYSTEMK913678TROCAR CATHETERK905478YANKAUER SUCTION DEVICEK874309URETHAL CATHETERK864963STOMACH EVACULATOR - EWALD STYLE

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Related Devices (Code: KNQ)

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.

K122924CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific CorpK093236ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.K090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook EndoscopyK082995SMART DILATORSafestitch MedicalK061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONCook EndoscopyK061787MAXFORCE TTS SINGLE-USE BALLOON DILATORBoston Scientific Corp

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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