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FDA 510(k)

LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION

K-Number: K924410 · 1993-06-25

ApplicantCore Dynamics, Inc.
Decision Date1993-06-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION 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 1993-06-25 under 510(k) number K924410. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION?

LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 1993-06-25. The listed applicant is Core Dynamics, Inc.. The 510(k) number is K924410.

When did LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION receive FDA 510(k) clearance?

LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION received FDA 510(k) clearance on 1993-06-25, under 510(k) number K924410.

Who is the listed applicant for LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION?

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 LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION?

The FDA product code for LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION is GEI.

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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: GEI)

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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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