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FDA 510(k)

TRI-MED QUICK-STEP(TM) RECTAL TUBE

K-Number: K924549 · 1994-02-10

ApplicantTri-Med Specialties, Inc.
Decision Date1994-02-10
Product CodeGBT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRI-MED QUICK-STEP(TM) RECTAL TUBE 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 1994-02-10 under 510(k) number K924549. The device is classified under product code GBT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-MED QUICK-STEP(TM) RECTAL TUBE?

TRI-MED QUICK-STEP(TM) RECTAL TUBE is a medical device that received FDA 510(k) clearance on 1994-02-10. The listed applicant is Tri-Med Specialties, Inc.. The 510(k) number is K924549.

When did TRI-MED QUICK-STEP(TM) RECTAL TUBE receive FDA 510(k) clearance?

TRI-MED QUICK-STEP(TM) RECTAL TUBE received FDA 510(k) clearance on 1994-02-10, under 510(k) number K924549.

Who is the listed applicant for TRI-MED QUICK-STEP(TM) RECTAL TUBE?

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 QUICK-STEP(TM) RECTAL TUBE?

The FDA product code for TRI-MED QUICK-STEP(TM) RECTAL TUBE is GBT.

Related Clinical Trials

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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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 FORCEPSK942918TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETERK950574NEEDLE/CANNULAK934348TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR

View all 14 devices →

Related Devices (Code: GBT)

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.

K941391INFLATABLE RETENTION CUFF SPECULUMInnovatec Medical Corp.K890466SIGMOID TONOMITORTonometrics, Inc.

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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