Search Results
Found 14 results
510(k) Data Aggregation
K Number
K002582Device Name
PILLING E-FRAZIER BIPOLAR SUCTION TUBE
Manufacturer
Date Cleared
2000-11-03
(77 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PILLING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K992476Device Name
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
Manufacturer
Date Cleared
2000-09-13
(415 days)
Regulation Number
870.4500Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Ask a Question
Ask a specific question about this device
K Number
K992174Device Name
PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
Manufacturer
Date Cleared
2000-03-23
(269 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Ask a Question
Ask a specific question about this device
K Number
K990935Device Name
JACKSON ESOPHAGEAL DILATOR
Manufacturer
Date Cleared
1999-05-17
(59 days)
Product Code
Regulation Number
876.5365Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
Ask a Question
Ask a specific question about this device
K Number
K990561Device Name
OPTICAL FORCEPS
Manufacturer
Date Cleared
1999-05-14
(81 days)
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Ask a Question
Ask a specific question about this device
K Number
K990547Device Name
PILLING WECK SURGICAL Y STENT FORCEPS
Manufacturer
Date Cleared
1999-04-27
(64 days)
Product Code
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
Ask a Question
Ask a specific question about this device
K Number
K982128Device Name
SHIKANI-FRENCH SPEAKING VALVE
Manufacturer
Date Cleared
1998-10-23
(128 days)
Product Code
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To allow airflow over the vocal cords for speaking To be used only as an attachment to CLJackson improved function. trachea tubes, manufactured by Pilling Weck Surgical.
Device Description
The Shikani-French Speaking Valve consists of a plastic outer body and a captured inner ball that forms the check valve. The assembly attaches to the C.L. Jackson Improved Stainless Steel Trachea Tube. Once in place, the valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal chords which facilitates speak.
Ask a Question
Ask a specific question about this device
K Number
K974250Device Name
VERSASTAT MULTIPOLAR SCISSORS AND CABLES
Manufacturer
Date Cleared
1998-02-11
(90 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
- to coagulate and transect vascular tissue simultaneously; .
- to perform spot coagulation of bleeding vessels; -
- to be used in open. surgical procedures; -
Device Description
The VersaStat™ MULTIPOLAR Sciators are non-starile, reuseble surgical devices with an insulated coating to schieve the congulation function. This device will be uvaliable in various sizes and shapes similar to conventional surgical sciaeors. One shaft incorporates three pole connectors that create the shillity of current flow for one or both blades willzing a monepolar or a bipolar mode. Located on the cables (monopolar and bipciar) is a switch allowing the use of either one blade or both blades as a cautery surface.
The VersaStat™ MULTIPOLAR Scissors are designed for we only with the VersaStat™ MULTIPOLAR Cables, either monopolar or bipolar, when connected to the uppropriate electrosurgical generator.
Ask a Question
Ask a specific question about this device
K Number
K971334Device Name
PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
Manufacturer
Date Cleared
1997-06-11
(62 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pilling Weck Secondary Flexible Sleeve with Cap and Trocar are manual surgical instruments used to support a cut down ( has approach) on secondary puncture placement.
The Trocar is used in Endoscopic Surgery (Gmecologic, general and other laparoscopic procedures and thoracic) for incision and peritoneal access for positioning of the hollow flexible sleeve.
Once the Trocar is removed, the port of entry provided by the sleeve through the cap, is used with manual instruments, laproscopes, and probes.
Device Description
The device consists of Trocar and Sleeves, with integral and separately available Single Use Disposable Caps. The Sterile Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.
The Optional Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.
The Trocar, sizes 3mm .- 15mm .. is constructed with a polymer hub and shaft with stainless steel tip and is available in pyramidal style.
The Sleeve, proportionally sized, is made of polymer and comes with or accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
Ask a Question
Ask a specific question about this device
K Number
K965176Device Name
PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
Manufacturer
Date Cleared
1997-03-04
(70 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pilling Weck 2-Piece Take-Apart Instrumentation is designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.
Device Description
The Pilling Weck 2-Piece Take-Apart Instrumentation are endoscopic instruments, which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the jaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle. The devices have reusable handles that accommodate inserts, that can be rotated 360 Degrees during use. Both devices include insulated and noninsulated handles, and accommodating shafts. In the Pilling Weck device there is included a flushing port to facilitate cleaning. All Pilling Weck device handles adapt the interchangeable working ends by inserting them through the inner diameter of the shaft that is an integral part of the handle. The fit is secured by a detented proximal end that locks securely in place by encapsulation with the actuation of a push button.
Ask a Question
Ask a specific question about this device
Page 1 of 2