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FDA 510(k)

PATTISON ESOPHAGEAL DILATOR

K-Number: K971615 · 1997-07-24

ApplicantTri-Med Specialties, Inc.
Decision Date1997-07-24
Product CodeKNQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PATTISON 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 1997-07-24 under 510(k) number K971615. 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 PATTISON ESOPHAGEAL DILATOR?

PATTISON ESOPHAGEAL DILATOR is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Tri-Med Specialties, Inc.. The 510(k) number is K971615.

When did PATTISON ESOPHAGEAL DILATOR receive FDA 510(k) clearance?

PATTISON ESOPHAGEAL DILATOR received FDA 510(k) clearance on 1997-07-24, under 510(k) number K971615.

Who is the listed applicant for PATTISON 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 PATTISON ESOPHAGEAL DILATOR?

The FDA product code for PATTISON ESOPHAGEAL DILATOR is KNQ.

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Other records listing Tri-Med Specialties, 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.

K970890#ES-32 SUCTION CATHETER 32 FR.K970982T-RX RETRIEVAL FORCEPSK942918TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETERK950574NEEDLE/CANNULAK934348TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FRK945160PARACENTESIS NEEDLES/CANNULAS

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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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