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FDA 510(k)

TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR

K-Number: K830586 · 1983-03-24

ApplicantKeymed, Inc.
Decision Date1983-03-24
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830586. 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 TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR?

TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Keymed, Inc.. The 510(k) number is K830586.

When did TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR receive FDA 510(k) clearance?

TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830586.

Who is the listed applicant for TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR?

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 TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR?

The FDA product code for TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR is KNQ.

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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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