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FDA 510(k)

KEYMED FLEXIBLE ESOPHAGEAL DILATORS

K-Number: K862000 · 1986-08-12

ApplicantKeymed, Inc.
Decision Date1986-08-12
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KEYMED FLEXIBLE ESOPHAGEAL DILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 1986-08-12 under 510(k) number K862000. 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 KEYMED FLEXIBLE ESOPHAGEAL DILATORS?

KEYMED FLEXIBLE ESOPHAGEAL DILATORS is a medical device that received FDA 510(k) clearance on 1986-08-12. The listed applicant is Keymed, Inc.. The 510(k) number is K862000.

When did KEYMED FLEXIBLE ESOPHAGEAL DILATORS receive FDA 510(k) clearance?

KEYMED FLEXIBLE ESOPHAGEAL DILATORS received FDA 510(k) clearance on 1986-08-12, under 510(k) number K862000.

Who is the listed applicant for KEYMED FLEXIBLE ESOPHAGEAL DILATORS?

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

What is the FDA product code for KEYMED FLEXIBLE ESOPHAGEAL DILATORS?

The FDA product code for KEYMED FLEXIBLE ESOPHAGEAL DILATORS is KNQ.

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Other records listing Keymed, 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.

K100803OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1K921179OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20K881004OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECRK861821KEYMED FIBERSCOPE AUTO DISINFECTORK864801THE KEYMED HI-LIGHT 250 LIGHT SOURCEK860528THE KEYMED FIBERSCOPE STERILIZATION CASE

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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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