Search Results
Found 7 results
510(k) Data Aggregation
K Number
K250598Device Name
Endoform Reconstructive Template - PLGA
Manufacturer
Aroa Biosurgery Ltd.
Date Cleared
2025-06-03
(95 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Aroa Biosurgery Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoform™ Reconstructive Template – PLGA is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing material to obtain the desired surgical outcome.
Device Description
Endoform™ Reconstructive Template – PLGA is a surgical mesh comprised of multiple layers of ovine-derived extracellular matrix reinforced with poly(lactic-co-Glycolic) acid (PLGA). The device design includes a range of shapes, sizes, and thicknesses in surface areas up to 400cm², to give a range of strengths as required for a particular implant procedure. Devices are terminally sterilized by ethylene oxide (EO) sterilization.
Ask a Question
K Number
K231305Device Name
Endoform Dental Membrane
Manufacturer
Aroa Biosurgery Ltd.
Date Cleared
2024-01-23
(263 days)
Product Code
NPL, NPM
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Aroa Biosurgery Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoform Dental Membrane is specifically intended for use in extraction sockets and soft tissue grafting. The device contains and prevents migration of guided bone regeneration graft material and prevents loss of alveolar height and ridge following tooth extraction. The device is provided sterile and intended for one-time use.
Device Description
Endoform Dental Membrane is an ovine derived bioabsorbable extracellular matrix intended for application in dental and periodontal procedures. The device is composed of non-cross linked and non-reconstituted collagen. The device is supplied sterile in a variety of sizes and thicknesses which may be trimmed by a licensed dentist or oral surgeon to meet individual patient needs.
Ask a Question
K Number
K223373Device Name
Enivo
Manufacturer
Aroa Biosurgery Ltd.
Date Cleared
2023-04-07
(154 days)
Product Code
BTA, DAT
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Aroa Biosurgery Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enivo™ is indicated for use to remove surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
Device Description
Enivo™ is a surgical drainage system intended for the removal of surgical and bodily fluids from a closed wound. The system can be used in both home and healthcare environments. The system includes two primary components: - A vacuum device unit that includes a single-use, portable, and battery-powered vacuum device that provides continuous operation for up to 30 days and a disposable exudate reservoir. - a removable silicone drainage catheter
Ask a Question
K Number
K200502Device Name
Myriad Particles
Manufacturer
Aroa Biosurgery Ltd.
Date Cleared
2021-03-31
(397 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Aroa Biosurgery Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Myriad™ Particles is indicated for use in the management of the following wounds:
- · 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 dehiscence)
- . trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears)
- · draining wounds
Device Description
Myriad™ Particles is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.
Ask a Question
K Number
K200413Device Name
Symphony
Manufacturer
Aroa Biosurgery Ltd.
Date Cleared
2020-07-29
(161 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Aroa Biosurgery Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Symphony™ is indicated for use in the management of the following wounds:
- · partial and full-thickness wounds
- · pressure ulcers
- venous ulcers
- · diabetic ulcers
- chronic vascular ulcers
- · tunnelled / undermined wounds
- · 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)
- draining wounds
Device Description
Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular collagen matrix. The 4-ply rectangular devices are available in sizes up to 200 cm².
Ask a Question
K Number
K183398Device Name
Endoform Restella
Manufacturer
Aroa Biosurgery Ltd.
Date Cleared
2019-04-11
(125 days)
Product Code
FTM, FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Aroa Biosurgery Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoform Restella is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Device Description
Endoform Restella is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with absorbable polyglycolic acid (PGA) and non-absorbable polypropylene (PP) suture material for use in plastic and reconstructive surgery. The 3-ply devices are available in sizes up to 400 cm² in arced rectangle, contour, and oval shapes.
Ask a Question
K Number
K181935Device Name
Endoform Reconstructive Template - Non Absorbable
Manufacturer
Aroa Biosurgery Ltd.
Date Cleared
2018-12-04
(138 days)
Product Code
FTL, FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Aroa Biosurgery Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoform Reconstructive Template – Non-Absorbable is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.
Endoform Reconstructive Template – Non-Absorbable is indicated for use in the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Device Description
Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with non-resorbable polypropylene (PP) suture material in a variety of sizes for use in soft tissue reconstruction. Devices up to 400 cm² are available in thicknesses from 1- through 10- ply, and larger devices up to 1000cm2 are available in 4-, 6-, and 8-ply presentations.
Ask a Question
Page 1 of 1