Search Results
Found 7 results
510(k) Data Aggregation
K Number
K233265Device Name
Monotime and Optime R
Manufacturer
Peters Surgical
Date Cleared
2024-10-11
(378 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
Peters Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.
Device Description
OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery. These sutures are available with a disposable needle attachment. OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
Ask a Question
K Number
K232372Device Name
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
Manufacturer
Peters Surgical
Date Cleared
2024-07-12
(339 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
Peters Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ADVANTIME® synthetic absorbable surgical sutures are intended for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery, and neurological tissue.
Device Description
ADVANTIME® sutures are intended to be used in suturing and/or tissue ligation in open or laparoscopic surgery. These sutures are available with a disposable needle attachment.
ADVANTIME® is a single use, sterile, single-stranded (monofilament), synthetic bioabsorbable thread made of a poliglecaprone (a copolymer of glycolide and E- caprolactone of low tissue reactivity). Sutures are commonly used in digestive, urological, aesthetic, gynecological and intradermal surgery. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. The same applies to double-armed needles. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.
Ask a Question
K Number
K071281Device Name
UNIRING - ANNULOPLASTY RING WITH SIZERS
Manufacturer
PETERS SURGICAL
Date Cleared
2007-08-03
(88 days)
Product Code
KRH
Regulation Number
870.3800Why did this record match?
Applicant Name (Manufacturer) :
PETERS SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNIRING® is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
Device Description
The UNIRING® consists of an annuloplasty ring mounted on a holder assembly for implantation in the mitral or tricuspid position. A complete set of instrumentation is available scparately to properly size the annulus.
Ask a Question
K Number
K060465Device Name
PREMIO
Manufacturer
PETERS SURGICAL
Date Cleared
2007-01-17
(329 days)
Product Code
MXW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
PETERS SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
Device Description
PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.
Ask a Question
K Number
K060163Device Name
CARDIOFLON, CARDIOXYL
Manufacturer
PETERS SURGICAL
Date Cleared
2006-10-11
(261 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
PETERS SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CARDIOFLON® and CARDIOXYL® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
Device Description
The synthetic non-absorbable surgical sutures CARDIOFLON® and CARDIOXYL® are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOFLON® braids are coated with a polymer of tetrafluorethylene (PTFE) and CARDIOXYL® braids are coated with polysiloxane. CARDIOFLON® and CARDIOXYL® sutures are green dyed (D&C green nº6 CI 61565) and white (undyed). Some packs are composed of green and white II is to facilitate location during use. CARDIOFLON® and CARDIOXYL® sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for nonabsorbable surgical sutures.
Ask a Question
K Number
K062366Device Name
OPTIME, SINUSORB PGA
Manufacturer
PETERS SURGICAL
Date Cleared
2006-10-02
(49 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
PETERS SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The synthetic absorbable surgical sutures OPTIME® and SINUSORB® PGA are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery; but not for use in cardiovascular and neurological surgery.
Device Description
OPTIME® and SINUSORB® PGA are synthetic absorbable braids composed of homopolymer of glycolic acid and coated with epsilon-caprolactone and calcium stearate or a mixture composed of polycaprolacton, calcium stearate and fatty acid ester. These surgical sutures are available undyed or violet dyed with an FDA approved color additive: D&C violet nº2, CI 60725. The suture may be provided with or without a standard needle attached.
Ask a Question
K Number
K052701Device Name
COROLENE
Manufacturer
PETERS SURGICAL
Date Cleared
2005-12-13
(76 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
PETERS SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
COROLENE® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery, in plastic surgery and in neurological surgery.
Device Description
COROLENE® is a monofilament synthetic non-absorbable surgical suture composed of polypropylene. The suture is available undyed or blue dyed with an FDA approved color additive: Phtalocyanine-copper (CI 74160), to enhance visibility. The suture may be provided with or without a standard needle attached.
Ask a Question
Page 1 of 1