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510(k) Data Aggregation
K Number
K113866Device Name
PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX
Manufacturer
BRENNEN MEDICAL, LLC
Date Cleared
2012-03-23
(84 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Porcine Dermal Xenograft is intended for the management of wounds that include: Partial and full thickness wounds; Pressure, diabetic, and venous ulcers; Chronic vascular ulcers; Second-degree burns; Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence; Trauma wounds-abrasions, lacerations, and skin tears; Tunneled/undermined wounds; Draining wounds. The Porcine Dermal Xenograft provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.
Device Description
Porcine Dermal Xenograft is an acellular, sterile, porcine dermal xenograft for use in treatment of topical wounds. The product is available in several sizes.
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K Number
K111436Device Name
PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
Manufacturer
BRENNEN MEDICAL, LLC
Date Cleared
2011-10-14
(143 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. Specifically indicated for: Plastic and reconstructive surgery; Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadriceps, or other tendons.
Device Description
Porcine Dermal Matrix is a prescription, sterile, single use, hydrated, non-crosslinked, r orcine skin that has both the epidermal and subdermal sides removed leaving only the dermis. The product is available in several sizes.
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K Number
K081272Device Name
PORCINE SURGICAL MESH; DERMAL MATRIX
Manufacturer
BRENNEN MEDICAL, LLC
Date Cleared
2008-07-31
(87 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BRENNEN MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including but not limited to: Plastic and reconstructive surgery: Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Device Description
Porcine Dermal Matrix is a prescription, sterile, pyrogen free, single use, porcine skin that has both the epidermal and subdermal sides removed. The product is available in several sizes.
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