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FDA 510(k)

OVER THE GUIDEWIRE DILATATION SYSTEM

K-Number: K924646 · 1994-12-05

ApplicantMedovations, Inc.
Decision Date1994-12-05
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OVER THE GUIDEWIRE DILATATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medovations, Inc.. It received FDA 510(k) clearance on 1994-12-05 under 510(k) number K924646. 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 OVER THE GUIDEWIRE DILATATION SYSTEM?

OVER THE GUIDEWIRE DILATATION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Medovations, Inc.. The 510(k) number is K924646.

When did OVER THE GUIDEWIRE DILATATION SYSTEM receive FDA 510(k) clearance?

OVER THE GUIDEWIRE DILATATION SYSTEM received FDA 510(k) clearance on 1994-12-05, under 510(k) number K924646.

Who is the listed applicant for OVER THE GUIDEWIRE DILATATION SYSTEM?

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 OVER THE GUIDEWIRE DILATATION SYSTEM?

The FDA product code for OVER THE GUIDEWIRE DILATATION SYSTEM 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.

K002363MEDOVATIONS ESOPHAGEAL DILATORK972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)K913678TROCAR 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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