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FDA 510(k)

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments

K-Number: K151036 · 2016-02-01

ApplicantCarefusion 2200, Inc.
Decision Date2016-02-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2016-02-01 under 510(k) number K151036. 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 Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments?

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2016-02-01. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K151036.

When did Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments receive FDA 510(k) clearance?

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments received FDA 510(k) clearance on 2016-02-01, under 510(k) number K151036.

Who is the listed applicant for Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments?

The FDA product code for Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments is GCJ.

Related Clinical Trials

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Other records listing Carefusion 2200, 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.

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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.

K261139VereSee (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.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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