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FDA 510(k)

LAPAROSCOPIC KNITTER

K-Number: K955490 · 1996-01-22

ApplicantCore Dynamics, Inc.
Decision Date1996-01-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC KNITTER 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 1996-01-22 under 510(k) number K955490. 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 LAPAROSCOPIC KNITTER?

LAPAROSCOPIC KNITTER is a medical device that received FDA 510(k) clearance on 1996-01-22. The listed applicant is Core Dynamics, Inc.. The 510(k) number is K955490.

When did LAPAROSCOPIC KNITTER receive FDA 510(k) clearance?

LAPAROSCOPIC KNITTER received FDA 510(k) clearance on 1996-01-22, under 510(k) number K955490.

Who is the listed applicant for LAPAROSCOPIC KNITTER?

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 KNITTER?

The FDA product code for LAPAROSCOPIC KNITTER 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 POUCHK953903LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MMK953409LAPAROSCOPIC TROCARK950457CANNUAL AND TROCAR, SUPERPUBICK943172CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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