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510(k) Data Aggregation
K Number
K233569Device Name
SeptAlign
Manufacturer
Spirair, Inc.
Date Cleared
2024-03-22
(137 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
Device Description
The Spirair SeptAlign implant is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. SeptAlign is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. SeptAlign is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle to enable attachment to the tissue which is trimmed off affer use. SeptAlignis provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.
The SeptAlign implantis provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. The SeptAlign implant and accessory delivery tool are provided sterile and are intended for single-use only.
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K Number
K223167Device Name
Spirair Nasal Septal Strap
Manufacturer
Spirair, Inc.
Date Cleared
2023-08-17
(314 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirair Nasal Septal Strap is used to support and straighten in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
Device Description
The Spirair Nasal Septal Strap is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. The Nasal Septal Strap is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. The Nasal Septal Strap is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle attachment to the tissue which is trimmed off after use. The Nasal Septal Strap is provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.
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K Number
K210411Device Name
PosiSep EAR Fragmentable Ear Dressing
Manufacturer
Hemostasis LLC
Date Cleared
2022-05-05
(448 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.
Device Description
The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.
PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.
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K Number
K192661Device Name
LATERA Absorbable Nasal Implant System
Manufacturer
Entellus Medical, Inc. (Aka Stryker ENT)
Date Cleared
2019-11-10
(46 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LATERA Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal cartilage.
Device Description
The LATERA Absorbable Nasal Implant System is intended to support upper and lower lateral cartilage in the nose. The system consists of the LATERA Absorbable Nasal Implant) and Delivery Device (Delivery Device). An Implant Positioning Guide is provided to serve as an external visual planning aid prior to Implant placement. The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and lengths of 20mm and 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16-gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. Each Implant length (20mm, 24mm) is compatible with the Delivery Device packaged with the Implant. The LATERA Absorbable Nasal Implant System is provided sterile and is intended for single-use only.
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K Number
K183015Device Name
PuraSinus
Manufacturer
3-D Matrix, Inc.
Date Cleared
2019-04-12
(163 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PuraSinus® is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.
PuraSinus® is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period.
Device Description
PuraSinus® is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraSinus® forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue.
PuraSinus® is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.
Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraSinus® can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.
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K Number
K161191Device Name
Latera Absorbable Nasal Implant
Manufacturer
SPIROX, INC.
Date Cleared
2016-06-23
(57 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirox Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
Device Description
The Spirox Latera Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the Latera Absorbable Nasal Implant) and Accessory Delivery Device (Delivery Device). The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and overall length of 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. The Latera Absorbable Nasal Implant and Accessory Delivery Device are provided sterile and are intended for single-use only.
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K Number
K152958Device Name
INEX Absorbable Nasal Implant
Manufacturer
SPIROX, INC.
Date Cleared
2015-12-04
(58 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirox INEX Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
Device Description
The Spirox INEX Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the INEX Absorbable Nasal Implant and accessory Delivery Tool. The implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and an overall length of 24mm. The distal end of the implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Tool is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Tool enables placement of the implant in a minimally invasive manner. The INEX Absorbable Nasal Implant and accessory Delivery Tool are provided sterile and are intended for single-use only.
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K Number
K132920Device Name
SPIROX INEX DEVICE
Manufacturer
SPIROX, INC.
Date Cleared
2014-06-10
(266 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirox INEX absorbable implant is indicated for supporting nasal septal cartilage.
Device Description
The Spirox INEX implantable sheet is an absorbable device comprised of a poly (L-lactide) 70:30. The product is provided as a perforated sheet comprised of multiple "rod" like elements. The sheet is nominally 24.5 x 20.0 mm with a thickness of 1.1 mm. The bridge sections are nominally 3.0 x 1.9 mm and the voids are nominally 2.4 x 1.9 mm. The implant can be trimmed and shaped to dimensions suitable for the surgical need. The device is implanted using standard surgical tools and techniques The Spirox INEX implantable sheet is a sterile, single use device.
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K Number
K122434Device Name
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
Manufacturer
MEDTRONIC XOMED
Date Cleared
2012-10-31
(82 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.
MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal / sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.
Device Description
MeroGel is a sterile, transparent, viscoelactic, bioresorbable gel composed of cross-linked polymers of hyaluronic acid. The MeroGel device fills ENT cavities following surgery or trauma to keep tissues or structures separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine ENT surgery. MeroGel leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.
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K Number
K092590Device Name
PDS PLATES
Manufacturer
ETHICON, INC.
Date Cleared
2010-02-17
(177 days)
Product Code
NHB
Regulation Number
874.3620Why did this record match?
Product Code :
NHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ethicon Inc. PDS Flexible Plates are indicated for:
– Nasal soft-tissue and cartilage reconstruction
Device Description
PDS Flexible Plate are made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerisation of the monomer p-dioxanone. PDS Flexible Plate are dyed with D+C violet # 2 (Color index Number 60725). PDS Flexible Plate are available in various film thicknesses, some of which are also perforated. PDS Flexible Plate can be trimmed to suit the anatomical conditions. The PDS Flexible Plate is a sterile, single use device.
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