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Found 21 results
510(k) Data Aggregation
K Number
K030311Device Name
HEM-O-LOK XL CLIP
Manufacturer
WECK
Date Cleared
2003-02-26
(27 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
WECK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Device Description
The Weck Hem-O-Lok™ ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-o-Lok™ causes hemostasis through vessel ligation. The modified XL size clip is a larger version of the existing Hem-o-lok clip.
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K Number
K021808Device Name
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
Manufacturer
WECK
Date Cleared
2002-08-14
(72 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
WECK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.
Device Description
The Weck device is a sterile, single use, automatic ligating clip applier consisting of a handle, shaft containing 15 Hem-o-lok® locking polymer clips, and jaw. The major functions of the device are clip feeding, approximation (positioning the clip around the vessel), and closure. The applier is discarded after the surgical procedure whereas the applied non-absorbable polymer clips remain in the patient. Two models are offered: endoscopic and open surgery.
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K Number
K011660Device Name
WECK CARDIAC PACING WIRES
Manufacturer
WECK CLOSURE SYSTEMS
Date Cleared
2001-08-21
(84 days)
Product Code
LDF
Regulation Number
870.3680Why did this record match?
Applicant Name (Manufacturer) :
WECK CLOSURE SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Weck Cardiac Pacing Wires are intended for use in temporary cardiac pacing following cardiac surgery in adult and pediatric patients.
Device Description
Weck cardiac pacing wires consist of a small curved stainless steel needle attached to fluoropolymer coated stainless steel braided wire which is attached on the opposite end to a Keith or Milner breakaway needle (see picture below). The wire is bare at the distal end to allow conduction of pacing signals to the heart. This is a standard temporary epicardial pacing wire design.
There are three design variations included in this submission that are offered as a convenience to the user:
1. Color coding White and orange color coding of the insulation allows the user to differentiate between atrial and ventricular wires after chest closure.
2. Heart needle Three heart needle sizes are intended to allow for variations in physiology between patients. Another variation has no curved heart needle for surgeons who prefer to suture the wire to the epicardium rather than implanting it.
3. Retention feature A "wing" version wire is formed by peeling back the insulation in three places, 120° apart, for a distance of 1/2" near the curved heart needle. The "wing" is intended as a convenience feature to provide a suture-free method of securing the electrode to the heart.
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K Number
K003337Device Name
HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
Manufacturer
WECK CLOSURE SYSTEMS
Date Cleared
2000-12-21
(57 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
WECK CLOSURE SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992476Device Name
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
Manufacturer
PILLING WECK SURGICAL
Date Cleared
2000-09-13
(415 days)
Product Code
MWS, MMS
Regulation Number
870.4500Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.
Device Description
Pilling Weck Surgical Stabilizer Removable Pads
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K Number
K992174Device Name
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
Manufacturer
PILLING WECK SURGICAL
Date Cleared
2000-03-23
(269 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.
Device Description
Aortic Spoon Jaw Clamp
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K Number
K993157Device Name
HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
Manufacturer
WECK CLOSURE SYSTEMS
Date Cleared
1999-12-17
(87 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
WECK CLOSURE SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Device Description
Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacetal.
The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10°. The blister packs are fitted into an overpack carton which serves as the sales unit.
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K Number
K990935Device Name
JACKSON ESOPHAGEAL DILATOR
Manufacturer
PILLING WECK SURGICAL
Date Cleared
1999-05-17
(59 days)
Product Code
KNQ
Regulation Number
876.5365Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for exploratory and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.
Device Description
Device consists of silicone tip, stainless steel rod and nylon sleeve.
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K Number
K990561Device Name
OPTICAL FORCEPS
Manufacturer
PILLING WECK SURGICAL
Date Cleared
1999-05-14
(81 days)
Product Code
JEK, EOX, EWY
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes
Device Description
The Optical Forcep consists of two components - a. Telescope - b. Biopsy Forcep
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K Number
K990547Device Name
PILLING WECK SURGICAL Y STENT FORCEPS
Manufacturer
PILLING WECK, INC.
Date Cleared
1999-04-27
(64 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid)is to inset tracheobronchial stents during ENT procedures
Device Description
The Stent Forceps/(Bronchoscope(Flexible or Rigid) consists of a hand controlled forcep with a specially designed grasping tip to restrain the bronchial limbs of the Y Stent and mechanically hold the stent limbs together for insertion into the trachea. Once positioned, the forceps are released and the bronchial limbs of the stent return to their Y position. The Forceps is then withdrawn.
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