Search Results
Found 4 results
510(k) Data Aggregation
K Number
K181320Device Name
Caprolon
Manufacturer
Resorba Medical GmbH
Date Cleared
2018-09-18
(123 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
Resorba Medical GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CAPROLON® is Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures
Device Description
CAPROLON® is a synthetic absorbable surgical suture. Primary material is Poly(L-lactide-co-ε-caprolactone), P(LA/CL) Material presentation is Monofilament Undyed and dyed (D&C violet No.2) variants Coated with a mixture of calcium stearate and the copolymer of L-lactide and ε-caprolactone Suture material is a sterile, flexible, thread offered in a variety of lengths (35cm to 90cm), reels, range of diameters (USP 7-0 to 2), with or without needles attached.
Ask a Question
K Number
K143584Device Name
PGA RESORBA, PGA RESOQUICK, GLYCOLON
Manufacturer
RESORBA MEDICAL GMBH
Date Cleared
2015-11-02
(319 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
RESORBA MEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GLYCOLON® is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
PGA RESORBA® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery or neural tissue.
PGA resoquick™ is indicated for use in general soft tissue approximation, including ophthalmic (e.g. conjunctiva) procedures, but not in cardiovascular or neurological procedures.
Device Description
The subject devices are synthetic absorbable surgical sutures.
PGA Resorba: Primary material Polyglycolic acid (PGA), Material presentation Multifilament, braided, Dyed or undyed Undyed and dyed D&C violet No.2, Coated or uncoated Coated Polycaprolactone + calcium stearate, Suture material is a sterile, flexible, thread offered in a variety of lengths, reels, range of diameters, with or without needles attached.
PGA resoquick: Primary material Polyglycolic acid (PGA), Material presentation Multifilament, braided, Dyed or undyed Undyed, Coated or uncoated Coated Polycaprolactone + calcium stearate, Suture material is a sterile, flexible, thread offered in a variety of lengths, reels, range of diameters, with or without needles attached.
Glycolon: Primary material Copolymer glycolide and E-caprolactone (PGA/CL), Material presentation Monofilament, Dyed or undyed Undyed and dyed D&C violet No.2, Coated or uncoated Uncoated, Suture material is a sterile, flexible, thread offered in a variety of lengths, reels, range of diameters, with or without needles attached.
Ask a Question
K Number
K143582Device Name
MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
Manufacturer
RESORBA MEDICAL GMBH
Date Cleared
2015-10-29
(315 days)
Product Code
GAW, GAP, GAQ, GAR, GAT, MXW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
RESORBA MEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
Device Description
The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.
Ask a Question
K Number
K141072Device Name
SUPOLENE
Manufacturer
RESORBA MEDICAL GMBH
Date Cleared
2014-06-23
(59 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
RESORBA MEDICAL GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1