MEDTRONIC CLIP GUN KIT— 510(k) K050044

Substantially Equivalent

Medtronic Neurosurgery

FDA 510(k) clearance K050044 for MEDTRONIC CLIP GUN KIT, Substantially Equivalent on 2005-02-07. Applicant: Medtronic Neurosurgery. Device class: 2.

Clearance details

Applicant: Medtronic Neurosurgery
Product code: Code HBO
Device class: Class 2
Regulation: 21 CFR 882.4150
Advisory panel: Neurology
Date received: 2005-01-10
Decision date: 2005-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K050044

K-number listed on FDA's recall record

Z-3212-2018 — Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single UseClass II·Terminated·Medtronic Neurosurgery·20180503
Z-0622-2018 — Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)Class II·Terminated·Medtronic Neurosurgery·20171220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050044.

Data sourced from openFDA. This site is unofficial and independent of the FDA.