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FDA 510(k)

MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)

K-Number: K972119 · 1998-02-02

ApplicantMedovations, Inc.
Decision Date1998-02-02
Product CodeFAT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) is the device name listed in this FDA 510(k) record. The listed applicant is Medovations, Inc.. It received FDA 510(k) clearance on 1998-02-02 under 510(k) number K972119. The device is classified under product code FAT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)?

MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) is a medical device that received FDA 510(k) clearance on 1998-02-02. The listed applicant is Medovations, Inc.. The 510(k) number is K972119.

When did MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) receive FDA 510(k) clearance?

MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) received FDA 510(k) clearance on 1998-02-02, under 510(k) number K972119.

Who is the listed applicant for MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)?

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 MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)?

The FDA product code for MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) is FAT.

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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 DILATORK924646OVER THE GUIDEWIRE DILATATION SYSTEMK913678TROCAR CATHETERK905478YANKAUER SUCTION DEVICEK874309URETHAL CATHETERK864963STOMACH EVACULATOR - EWALD STYLE

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Related Devices (Code: FAT)

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.

K983220STRYKER INFRAVISION ESOPHAGEAL KITStryker EndoscopyK960173INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KITGabriel Medical, Inc.K901425PYLORIC BALLOON DILATORTelemed Systems, Inc.K843186ESKA MULTISTAGE ESOPHAGEAL BOUGIEDacomed Corp.K842679ESOPHAGEAL DILATOR SETMill-Rose LaboratoryK780471GASTRIC LAVAGE KITGaymar Industries, Inc.

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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