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FDA 510(k)

CORE DISPOSABLE SUCTION/IRRIGATION TUBING

K-Number: K910246 · 1991-04-29

ApplicantCore Dynamics, Inc.
Decision Date1991-04-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORE DISPOSABLE SUCTION/IRRIGATION TUBING 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 1991-04-29 under 510(k) number K910246. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE DISPOSABLE SUCTION/IRRIGATION TUBING?

CORE DISPOSABLE SUCTION/IRRIGATION TUBING is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Core Dynamics, Inc.. The 510(k) number is K910246.

When did CORE DISPOSABLE SUCTION/IRRIGATION TUBING receive FDA 510(k) clearance?

CORE DISPOSABLE SUCTION/IRRIGATION TUBING received FDA 510(k) clearance on 1991-04-29, under 510(k) number K910246.

Who is the listed applicant for CORE DISPOSABLE SUCTION/IRRIGATION TUBING?

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 CORE DISPOSABLE SUCTION/IRRIGATION TUBING?

The FDA product code for CORE DISPOSABLE SUCTION/IRRIGATION TUBING is GCJ.

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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: GCJ)

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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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