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510(k) Data Aggregation
K Number
K221487Device Name
NEOVEIL Staple Line Reinforcement
Manufacturer
Gunze Limited
Date Cleared
2022-08-26
(95 days)
Product Code
OXC
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Gunze Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NEOVEIL® Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. NEOVEIL® Staple Line Reinforcement of staple lines during lung resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.
Device Description
NEOVEIL® Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid (PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6.
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K Number
K213498Device Name
PELNAC Meshed Bilayer Wound Matrix
Manufacturer
Gunze Limited
Date Cleared
2022-07-14
(255 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Gunze Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PELNAC® Meshed Bilayer Wound Matrix is indicated for the management of wounds including:
- · partial and full-thickness wounds,
- · pressure ulcers,
- · venous ulcers,
- · diabetic ulcers,
- · chronic vascular ulcers,
- · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- · trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears), and
- · draining wounds.
The device may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.
Device Description
PELNAC® Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine derived sponge layer and a silicone film layer. Slits are added to the silicone and collagen layers to aid in the drainage of exudate. When applied to full-thickness skin defects, PELNAC® provides a scaffold for cellular invasion and capillary growth. The device is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
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K Number
K213573Device Name
PELNAC Wound Matrix
Manufacturer
Gunze Limited
Date Cleared
2022-02-09
(91 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Gunze Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PELNAC® Wound Matrix is indicated for the management of wounds including:
- · partial and full-thickness wounds,
- · pressure ulcers,
- · venous ulcers,
- · diabetic ulcers,
- · chronic vascular ulcers,
- · tunneled/undermined wounds,
- · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound deliscence),
- · trauma wounds (abrasions, lacerations, partial thickness burns and skin tears), and
- · draining wounds.
The device is intended for one-time use.
Device Description
PELNAC® Wound Matrix is a single layer wound matrix of 100% atelocollagen sponge derived from porcine Achiles tendon that is applied directly to the wound surface. When applied to full-thickness skin defects, PELNAC® Wound Matrix provides a scaffold for cellular invasion and capillary growth. The device is offered in sheet form of various sizes and in two levels of thickness and is provided terminally sterilized by ethylene oxide. PELNAC® Wound Matrix is for single patient use and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
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K Number
K191992Device Name
PELNAC Bilayer Wound Matrix
Manufacturer
Gunze Limited
Date Cleared
2020-04-29
(279 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Gunze Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PELNAC™ Bilayer Wound Matrix is indicated for the management of wounds including:
- · partial and full-thickness wounds,
- · pressure ulcers,
- · venous ulcers,
- · diabetic ulcers,
- · chronic vascular ulcers,
- · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- · trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and
- · draining wounds.
The device is intended for one-time use.
Device Description
PELNAC™ Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer and is offered in two versions: 1. Meshed Type (i.e., fenestrated) and 2. Non-Meshed Type (i.e., non-fenestrated). The collagen sponge layer should be applied to the wound surface. Both versions of the device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, PELNAC™ Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. PELNAC™ Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
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K Number
K130997Device Name
NEOVEIL
Manufacturer
GUNZE LIMITED
Date Cleared
2013-11-15
(219 days)
Product Code
OXC, GOR
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
GUNZE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NEOVEIL™ is indicated for use in surgical procedures in which soft tissue transection or resection with suture or staple line reinforcement is needed. NEOVEIL™ can be used for reinforcement of suture or staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.
Device Description
As packaged, NEOVEIL™ is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL TM are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL™ staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL™ is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m²).
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