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Found 9 results
510(k) Data Aggregation
K Number
K221524Device Name
Sugita AVM Microclip Applier
Manufacturer
Mizuho America, Inc.
Date Cleared
2022-06-24
(29 days)
Product Code
HCI
Regulation Number
882.4175Why did this record match?
Product Code :
HCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sugita AVM Microclip Applier is exclusively designed to place Sugita AVM Microclips during surgical procedures.
Device Description
The Sugita AVM Microclip Applier has a spring handle design with a ratchet. The Sugita AVM Microclip Applier serves to open and close the Sugita AVM Microclips. Using the Sugita AVM Microclip Applier, the Sugita AVM Microclips are removed from their packaging and applied, repositioned or removed from the target tissue. The Sugita AVM Microclip Applier has no function of its own and may only be used in combination with the Sugita AVM Microclips. The Sugita AVM Microclip Applier has the same design and materials as the clip applier in the K960037. The body of the Sugita AVM Microclip Applier is manufactured from stainless steel and the jaws are manufactured from Elgiloy, a cobalt-chromium-molybdenum alloy.
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K Number
K211572Device Name
Aesculap Slim Clip Applier
Manufacturer
Aesculap, Inc
Date Cleared
2021-12-13
(206 days)
Product Code
HCI
Regulation Number
882.4175Why did this record match?
Product Code :
HCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips.
Device Description
The Aesculap Slim Clip Appliers are manufactured from stainless steel and are available in various lengths, jaw angulations, with or without latches. This submission intends to add a coating to the previously cleared clip appliers. Each clip applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.
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K Number
K180914Device Name
Aesculap Slim Clip Applier
Manufacturer
Aesculap, Inc.
Date Cleared
2018-04-17
(8 days)
Product Code
HCI
Regulation Number
882.4175Why did this record match?
Product Code :
HCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aesculap Slip Clip Applier forceps are used for opening, closing, and applying Aesculap Y ASARGIL aneurysm clips.
Device Description
The Aesculap Slim Clip Appliers are manufactured from stainless steel (body & jaw). The previously cleared appliers are available in lengths ranging from 50 mm to 110 mm in 10 mm increments. In addition to the straight jaw configuration (0%), the Clip Appliers are available with jaws angled up & down (5° to 15°), left & right (5° to 15°), in increments of 5° in all lengths. This submission intends to add additional lengths of 120 mm and 130 mm in these configurations. This submission intends to add additional jaw angulations of 20° to 45° up and down and 20° to 30° left and right in 5° increments and lengths ranging from 50-130 mm in 10 mm increments. In addition to these configurations, clip appliers with latches will be available in lengths ranging from 70 mm to 110 mm increments with jaw angulations ranging from straight, 5° to 45° up and down and 5° to 30° left and right in 5° increments. Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.
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K Number
K173271Device Name
Aesculap Slim Clip Applier Forceps
Manufacturer
Aesculap, Inc.
Date Cleared
2017-11-10
(29 days)
Product Code
HCI
Regulation Number
882.4175Why did this record match?
Product Code :
HCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aesculap Slim Clip Applier forceps are used for opening, closing, and applying Aesculap YASARGIL aneurysm clips.
Device Description
The Aesculap Slim Clip Applier forceps are manufactured from stainless steel (body & jaw). The appliers are available in lengths ranging from 50 mm to 110 mm. In addition to the straight jaw configuration, the Clip Appliers are available with jaws angled up & down, left & right.
Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, identification plugs to easily identify each clip designation are placed in the handles.
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K Number
K010910Device Name
MEDICON YASARGIL CLIP APPLYING FORCEPS
Manufacturer
MEDICON, E.G.
Date Cleared
2001-08-01
(128 days)
Product Code
HCI
Regulation Number
882.4175Why did this record match?
Product Code :
HCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994191Device Name
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
Manufacturer
NMT MEDICAL, INC.
Date Cleared
2000-02-08
(57 days)
Product Code
HCI
Regulation Number
882.4175Why did this record match?
Product Code :
HCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during intracranial aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the intracranial aneurysm.
The Spetzler™ Round-Handled Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.
Device Description
There are two types of Spetzler™ Round Handle Appliers; Stainless Steel with Titanium Jaws and Pads and completely Titanium. Each type applier has two styles; straight and bayonet.
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K Number
K984109Device Name
AESCULAP AXIAL CLIP APPLIER
Manufacturer
AESCULAP, INC.
Date Cleared
1999-02-12
(87 days)
Product Code
HCI
Regulation Number
882.4175Why did this record match?
Product Code :
HCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.
Device Description
There are twelve Axial clip appliers; each with complete material and design compatibility with Aesculap's existing Yasargil titanium and phynox aneurysm clip patterns. The new Axial clip appliers are available in three lengths (70mm, 90mm, 110mm), two jaw sizes (mini and standard), and two jaw materials (phynox and titanium).
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K Number
K982379Device Name
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
Manufacturer
JOHNSON & JOHNSON PROFESSIONALS, INC.
Date Cleared
1998-12-18
(163 days)
Product Code
HCI, SUN
Regulation Number
882.4175Why did this record match?
Product Code :
HCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sundt Slim-Line Aneurysm Clip Applier is designed for use only with Sundt Slim-Line Aneurysm Clips.
Device Description
The subject Sundt Slim-Line Aneurysm Clip Applier is a stainless steel reusable hand-held instrument that is available in two configurations a fixed tip applier and a hinged tip applier. All three appliers consist of a handle grip with serrations, a two-piece spring, a shaft, and a v-grooved shape tip for grasping the aneurysm clip. The fixed tip Sundt Slim-Line Aneurysm Clip Applier and the Sugita appliers are designed with shaft that angles down and a thin tip profile to provide the surgeon a greater field of view during clip placement.
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K Number
K954658Device Name
PERNECZKY CLIP APPLIER/REMOVER
Manufacturer
VON ZEPPELIN GMBH
Date Cleared
1996-10-08
(364 days)
Product Code
HCI
Regulation Number
882.4175Why did this record match?
Product Code :
HCI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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