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FDA 510(k)

TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER

K-Number: K942918 · 1995-02-28

ApplicantTri-Med Specialties, Inc.
Decision Date1995-02-28
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER 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 1995-02-28 under 510(k) number K942918. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER?

TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER is a medical device that received FDA 510(k) clearance on 1995-02-28. The listed applicant is Tri-Med Specialties, Inc.. The 510(k) number is K942918.

When did TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER receive FDA 510(k) clearance?

TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER received FDA 510(k) clearance on 1995-02-28, under 510(k) number K942918.

Who is the listed applicant for TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER?

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 ENDOSCOPIC FLUID INTRODUCTION CATHETER?

The FDA product code for TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER is OCX.

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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.

K971615PATTISON ESOPHAGEAL DILATORK970890#ES-32 SUCTION CATHETER 32 FR.K970982T-RX RETRIEVAL FORCEPSK950574NEEDLE/CANNULAK934348TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FRK945160PARACENTESIS NEEDLES/CANNULAS

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Related Devices (Code: OCX)

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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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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