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FDA 510(k)

BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO

K-Number: K926477 · 1993-11-12

ApplicantCore Dynamics, Inc.
Decision Date1993-11-12
Product CodeGBW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO is the device name listed in this FDA 510(k) record. The listed applicant is Core Dynamics, Inc.. It received FDA 510(k) clearance on 1993-11-12 under 510(k) number K926477. The device is classified under product code GBW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO?

BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO is a medical device that received FDA 510(k) clearance on 1993-11-12. The listed applicant is Core Dynamics, Inc.. The 510(k) number is K926477.

When did BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO receive FDA 510(k) clearance?

BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO received FDA 510(k) clearance on 1993-11-12, under 510(k) number K926477.

Who is the listed applicant for BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO?

The FDA 510(k) record lists Core Dynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO?

The FDA product code for BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO is GBW.

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Other records listing Core Dynamics, 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.

K992250CORE AUDIBLE TROCAR IIK992190CORE POUCHK955490LAPAROSCOPIC KNITTERK953903LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MMK953409LAPAROSCOPIC TROCARK950457CANNUAL AND TROCAR, SUPERPUBIC

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Related Devices (Code: GBW)

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.

K992907INTRADUCERTaut, Inc.K992904MINI-PORTTaut, Inc.K972112INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450Taut, Inc.K961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAINSil-Med Corp.K960426MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETERMedical Components, Inc.K942709MEDIASTINAL SILICONE DRAINSSil-Med 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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