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510(k) Data Aggregation
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 The Forceps is then withdrawn.
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K Number
K974250Device Name
VERSASTAT MULTIPOLAR SCISSORS AND CABLES
Manufacturer
PILLING WECK, INC.
Date Cleared
1998-02-11
(90 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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K Number
K962771Device Name
BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
Manufacturer
PILLING WECK, INC.
Date Cleared
1996-11-19
(126 days)
Product Code
DWS
Regulation Number
870.4500Why did this record match?
Applicant Name (Manufacturer) :
PILLING WECK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SPECIFIC INDICATION OF USE: PATENT DUCTUS ARTERIOSUS INTERRUPTION
INTENDED USES: intended for use for General Pediatric Surgery where visualization in confined anatomic spaces minimizing tissue trauma are needed. These instruments are designed to be used in Video-Assisted Thoracoscopic Surgery (VATS). Where size constraints are limiting and immature tissues are potentially vulnerable to mechanical injury.
INDICATIONS: Pediatric Thoracoscopic Procedures Patent Ductus Arteriosus Interruption (PDA)
CONTRA INDICATIONS: For PDA patients with a ductal diameter over 1 cm calcification, presence of a transcatheter device within the ductal lumen, patients with dense pleural adhesions.
Device Description
These instruments are equivalent to Thoracoscopy instruments for adult sizes but have a reduced dimension with a modified geometric configuration to meet reduced size requirements. These are modifications therefore of equivalent surgical instruments that can be used in general pediatric surgery but also have been designed specifically for pediatric thoracoscopic surgery. Instruments that are needed for the surgical procedures are cannula, lung retractor, clip appliers, grasping forceps with ratchets, scissors, hooks, and clamps. These instruments have specific overtures and dimensions suited for this surgical procedure.
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