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510(k) Data Aggregation
K Number
K983630Device Name
SEARE BIOMEDICAL SILICONE RODS
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-12-11
(57 days)
Product Code
MIB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SEARE BIOMEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seare Biomedical Silicone Rods are intended for use in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion to create an implant to aid in the reconstruction process. Some uses have been as temporary stents for the formation of new tendon sheaths, as well as other uses in surgical repair procedures demanding a highly inert and flexible rod shaped material as deemed appropriate by the using surgeon.
Device Description
Seare Biomedical Silicone Rods are made from specially formulated silicone elastomers designed for implantation. The intended use of the Seare Biomenical silicone rod is for forming a finished device by the surgeon for his or her own custom use. Seare Biomedical Silicone Rods are in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The Seare Biomedical Silicone Rods will be provided in 15cm or 30 cm lengtiss, 3FR - 28FR sizes, sterile and nonsterile. The durometers or hardness (Shore A) will range from 5 to 60. The appearance is dear to slightly opaque. Surface characteristics will vary from smooth to varving degrees of texturing and porosity.
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K Number
K983792Device Name
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-12-11
(45 days)
Product Code
LCJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SEARE BIOMEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.
Device Description
Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage. The tissue expander assemblies are designed to be implanted completely under the skin, and filled externally via a syringe. All tissue expandic, incremental inflation with sterile saline for injection, until the desired amount of tissue is developed. The Seare Biomedical Silicone Tissue Expanders are constructed as a unit from silicone elastomer and consist of an expansion envelope with a smooth surface, a silicone connection tube, and a remote injection site. The expanders are available in a wide range of styles and sizes to meet diverse surgical needs.
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K Number
K982752Device Name
SEARE BIOMEDICAL CHIN IMPLANTS
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-09-30
(55 days)
Product Code
FWP, EWP
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SEARE BIOMEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seare Biomedical Chin Implants are utilized to augment or reconstruct the chin or anterior mandibular contour.
Device Description
Seare Biomedical Chin Implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. The chin implant is used to augment or reconstruct the chin. It is placed over the anterior aspect of the mandible in the midline and placed under the periosteum. It is inserted via an intra-oral or submental incision according to the surgeon's preference. The Seare Biomedical Chins will be available in many sizes and styles, all of which are very similar differing only by a few millimeters in length and projection. The Seare Biomedical Chin Implants will be provided sterile and nonsterile.
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K Number
K982753Device Name
SEARE BIOMEDICAL NASAL IMPLANTS
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-09-30
(55 days)
Product Code
FZE
Regulation Number
878.3680Why did this record match?
Applicant Name (Manufacturer) :
SEARE BIOMEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seare Biomedical Nasal Implants are intended for use in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
Device Description
"L" shaped or straight with a concave convex dorsal aspect which reaches from the alar cartilage to the radix. These silicone rubber implants are made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. Seare Biomedical Nasal Implants are intended for use in augmentation of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision. The Seare Biomedical Nasal Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Seare Biomedical Nasal Implants will be provided sterile. Thanium Oxide and Iron Oxide pigments may be added to the silicone to prevent light translucence to these implants when ordered by the physician. These pigments are well known and widely used in cosmetic surgery implant applications, and will be lot tested for cytotoxicity.
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K Number
K982762Device Name
SEARE BIOMEDICAL PECTORALIS IMPLANT
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-09-30
(55 days)
Product Code
MIC
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SEARE BIOMEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seare Biomedical Pectoralis Implants / silicone carving blocks are intended to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle).
Device Description
Searc Biomedical Pectoralis implants are essentially large conceve conver on interestion. They are exponied Device Description: Seare Bromsonally formulated silicone elastomers designed for implantation. They are novided in two (2) orientations for cach of the specially formation and only in the milablity. Surface characterity will way ironton beeks on intended to smooth to varying degrees of lexturing and pornsity. Seare Biometical Pectoralis Implants / silicone carving block same intended to smood for augmenting the chest by placing the inplant in the submuseular space via a trans-axillary incision. The Career Ricer be used to reconstruct the pectoralis depression of Poland's Syndrone Congenitally Absent Pectoralis Muscle). The Seare Biomedical used to reconstition the pectoralis deplession of rolance congramilar - differing in length and proccion. The length of these implants varies from 11.5cm to 20cm. The height varies from 9cm to 18cm and the thickness at the apex varies 1cm to 3.5cm. The Seare Biomedical Pectoralis Implants will be provided sterile and nonsterile.
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K Number
K982763Device Name
SEARE BIOMEDICAL MALAR IMPLANTS
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-09-30
(55 days)
Product Code
LZK
Regulation Number
878.3550Why did this record match?
Applicant Name (Manufacturer) :
SEARE BIOMEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery.
Device Description
Seare Biomedical Malar implants are crescent shaped convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. Surface characteristics will varying degrees of texturing and porosity. Seare Biomedical Malar Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery. The Seare Biomedical Malar Implants will be produced using standard manufacturing molding techniques. The Searc Biomedical Malar Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Searc Biomedical Malar Implants will be provided sterile and nonsterile.
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K Number
K983041Device Name
SEARE BIOMEDICAL SILICONE SHEETING
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-09-30
(30 days)
Product Code
MIB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SEARE BIOMEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For short term application the indications for use are: nasal splinting; wound dressings; management of hypentrophic or kcloid scarring; to prevent soft tissue fibrosis or bony ankylosis following surgical concction of trismus; temporary joint spacers; and laboratory uses. For long-term application the indications for use are: nasal septal repair; orbital floor reconstruction; tympanic membrane repair: dialysis shunt anchoring: duramater repair: staged repair of omphaloccic; for lengthening extra ocular muscles in select cases of strabismus; as a protective sheathing to help facilitate neural regeneration and tendon anastomosis; as a protective sheathing to help facilitate osteogenesis; guided tissue regeneration between teeth and gingival margin, or external ear canal for example; other uses deemed appropriate by the using surgeon. Warning: Not for permanent use in Temporo Mundibular Joint applications.
Device Description
Seare Biomedical Silicone Sheeting is thate from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer Seare Biomer Sheeting is a flexible, translucent, medical grade silicone elastomer sheeting material designed for a variety of implant applications. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. Surface characteristics will varying degrees of texturing and porosity. The Silicone Sheeting may be readily trimmed with a knife or scissors. This trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable prosthesis for a specific surgical indication.
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K Number
K983043Device Name
SEARE BIOMEDICAL SILICONE BLOCK
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-09-30
(30 days)
Product Code
MIC
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
SEARE BIOMEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seare Biomedical Silicone Blocks are intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The contour carving blocks lend themselves to carving chin implants and malar implants.
Device Description
Searc Biomedical Silicone Blocks are made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer. The intended use of the Seare Biomedical silicone block is for caring a finished device by the surgeon for his or her own custom use. The square or rectangular blocks are designed for carving flater devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carved devices such as malar and chin implants. The Seare Biomedical Silicone Blocks will be provided sterile. The appearance is described as clear to slightly opaque. Pigments will optionally be added such as Iron Oxide, to create opacity to light and Radiographic exam.
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