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510(k) Data Aggregation
K Number
K234131Device Name
Resolv Endoscopic Hemostat System
Manufacturer
Hemostasis LLC
Date Cleared
2024-07-26
(211 days)
Product Code
QAU
Regulation Number
878.4456Why did this record match?
Applicant Name (Manufacturer) :
Hemostasis LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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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?
Applicant Name (Manufacturer) :
Hemostasis LLC
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
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?
Applicant Name (Manufacturer) :
Hemostasis LLC
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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