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Found 21 results
510(k) Data Aggregation
K Number
K220326Device Name
PosiSep X BAM Hemostat Dressing/Intranasal Splint
Manufacturer
Hemostasis LLC
Date Cleared
2022-11-14
(283 days)
Product Code
EMX, LYA
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PosiSep® X BAM Hemostat Dressing/Intranasal Splint is indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:
- Separate tissue or structures compromised by surgical trauma;
- Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity;
- Help control minimal bleeding following surgery or trauma;
- Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and
- Act as an adjunct to aid in the natural healing process
PosiSep® X BAM is indicated for use as a nasal hemostat to treat epistaxis. PosiSep® X BAM is intended for use under the direction of a licensed healthcare provider.
Device Description
The Hemostasis PosiSep® X BAM is placed in the nasal cavity after sinus surgery to prevent adhesions, control mild bleeding, and provide a level of protection against bacteria and fungi. PosiSep X BAM is supplied as a compressed foam, and it quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. Upon hydration, PosiSep® X BAM expands to contact and conform to the surrounding anatomy.
PosiSep X BAM is comprised of N, O-Carboxymethyl Chitosan derived from non-shell fish based Chitosan, modified Cellulose, and antimicrobial agents.
PosiSep® X BAM is fragmentable and eliminated from the site of application by natural excretion through the action of cilia.
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K Number
K041446Device Name
NASALCEASE
Manufacturer
LES LABORATORIRES BROTHIER, S.A.
Date Cleared
2004-07-01
(30 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NasalCEASE™ is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device.
Device Description
NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity.
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K Number
K000108Device Name
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
Manufacturer
BHK HOLDING
Date Cleared
2000-05-23
(130 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993362Device Name
HYLASINE
Manufacturer
BIOMATRIX, INC.
Date Cleared
2000-03-13
(159 days)
Product Code
EMX, 77E
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of Hylasine™ is for use in nasal/sinus cavity as a space-occupying gel stent, to separate mucosal surface and to help control minimal bleeding following surgery or nasal trauma.
Device Description
Hylasine™ is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. Due to its physical properties, Hylasine may be used to reduce synechiae and middle meatal stenosis. Its tamponade effect may also contribute to controlling bleeding. Hylasine 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
K983276Device Name
HYDROFERA BACTERISTATIC NASAL DRESSING
Manufacturer
HYDROFERA, LLC.
Date Cleared
1999-09-14
(362 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.
Device Description
BACTERISTATIC NASAL DRESSING
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K Number
K982731Device Name
MEROGEL NASAL DRESSING AND SINUS STENT
Manufacturer
XOMED, INC.
Date Cleared
1999-02-02
(181 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Xomed MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.
Device Description
Xomed MeroGel™ Nasal Dressing and Sinus Stent is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of the extracellular matrix. Due to its absorption properties, MeroGel™ may be used to help control minimal bleeding. In contact with body fluids, it changes into viscous and transparent gel, conforming to mucosal surfaces and eventually dissolves or may be irrigated from the cavity.
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K Number
K984069Device Name
ENTAXIS NASAL PACKING
Manufacturer
LES LABORATORIRES BROTHIER, S.A.
Date Cleared
1999-01-25
(70 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ENTaxis™ Nasal Packing is intended for
- Epistaxis
- Post operative nasal packing
Device Description
ENTaxis™ Nasal Packings are highly conformable, sterile, hemostatic packings designed for managing bleeding in the nasal cavity and as post operative packings. ENTaxis™ nasal packings are 12" (30cm, 2g) "ropes" that are 100% composed of pure calcium alginate fibers.
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K Number
K981966Device Name
NOSEBLEED NOSECLIP
Manufacturer
MICHAEL M. KNOTT, M.D.
Date Cleared
1998-08-14
(71 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The treatment of simple anterior (front) nosebleeds by application of a noseclip to the external nose in adults and children. Not for use on infants.
Device Description
Existing respiratory noseclip is to be used to treat simple anterior (front) nosebleeds.
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K Number
K973085Device Name
ULTRACELL PACKING WITH SLEEVE
Manufacturer
ULTRACELL MEDICAL TECHNOLOGIES, INC.
Date Cleared
1997-11-18
(92 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.
Device Description
Not Found
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K Number
K973656Device Name
DISPOSABLE SILICONE EPISTAXIS CATHETER
Manufacturer
SPECIALTY SURGICAL PRODUCTS, INC.
Date Cleared
1997-11-18
(54 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Product Code :
EMX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may r he baneler is a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.
Device Description
Disposable Sillicone Epistaxis Catheter
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