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FDA 510(k)

GASTROINTESTINAL DILATOR

K-Number: K841310 · 1984-07-31

ApplicantThomas J. Fogarty, M.D.
Decision Date1984-07-31
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASTROINTESTINAL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Thomas J. Fogarty, M.D.. It received FDA 510(k) clearance on 1984-07-31 under 510(k) number K841310. 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 GASTROINTESTINAL DILATOR?

GASTROINTESTINAL DILATOR is a medical device that received FDA 510(k) clearance on 1984-07-31. The listed applicant is Thomas J. Fogarty, M.D.. The 510(k) number is K841310.

When did GASTROINTESTINAL DILATOR receive FDA 510(k) clearance?

GASTROINTESTINAL DILATOR received FDA 510(k) clearance on 1984-07-31, under 510(k) number K841310.

Who is the listed applicant for GASTROINTESTINAL DILATOR?

The FDA 510(k) record lists Thomas J. Fogarty, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GASTROINTESTINAL DILATOR?

The FDA product code for GASTROINTESTINAL DILATOR is KNQ.

Related Clinical Trials

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.

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Other records listing Thomas J. Fogarty, M.D. 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.

K902453OSCILLOMETRIC PULSE DETECTION DEVICEK884154TRANSLUMINAL ENDARTERECTOMY DEVICEK831809FOGARTY OCCLUDER PADK834451COAXIAL BALLOON GASTROESOPHAGEAL DILAK831384COAXIAL BALLOON URETHRAL DILATOR

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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