FDA 510(k)

TRI-MED INFLATABLE ESOPHAGEAL DILATOR

K-Number: K932015 · 1994-02-03

Decision Date1994-02-03

Product CodeKNQ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TRI-MED INFLATABLE ESOPHAGEAL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Med Specialties, Inc.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K932015. 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-MED INFLATABLE ESOPHAGEAL DILATOR?

TRI-MED INFLATABLE ESOPHAGEAL DILATOR is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Tri-Med Specialties, Inc.. The 510(k) number is K932015.

When did TRI-MED INFLATABLE ESOPHAGEAL DILATOR receive FDA 510(k) clearance?

TRI-MED INFLATABLE ESOPHAGEAL DILATOR received FDA 510(k) clearance on 1994-02-03, under 510(k) number K932015.

Who is the listed applicant for TRI-MED INFLATABLE ESOPHAGEAL DILATOR?

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

What is the FDA product code for TRI-MED INFLATABLE ESOPHAGEAL DILATOR?

The FDA product code for TRI-MED INFLATABLE ESOPHAGEAL DILATOR is KNQ.

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Other records listing Tri-Med Specialties, Inc. as applicant

K971615PATTISON ESOPHAGEAL DILATOR K970890#ES-32 SUCTION CATHETER 32 FR.K970982T-RX RETRIEVAL FORCEPS K942918TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER K950574NEEDLE/CANNULA K934348TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR

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Related Devices (Code: KNQ)

K122924CRE FIXED WIRE BALLON DILATION CATHETERBoston Scientific Corp K093236ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.K090183HERCULES 3 STAGE WIRE GUIDED DILATION BALLOONCook Endoscopy K082995SMART DILATORSafestitch Medical K061937COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONCook Endoscopy K061787MAXFORCE 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.