BEUDAMED
    Product Code: GAW FDA class 2 21 CFR 878.5010

    Suture, Nonabsorbable, Synthetic, Polypropylene

    General, Plastic Surgery

    The Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW) is a monofilament synthetic suture made from polypropylene, widely used in general and plastic surgery for skin closure, cardiovascular procedures, and applications requiring minimal tissue reactivity and long-term tensile strength. It is classified as FDA Class 2, which requires a 510(k) premarket notification. The device is regulated under 21 CFR 878.5010 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is threaded through living tissue during use.

    View on FDA
    510(k)s
    84
    FEI Numbers
    111
    Registration Numbers
    111
    Unique Applicants
    57
    Years Active
    33

    Basic Information

    Product Code
    GAW
    Device Class
    FDA class 2
    Regulation Number
    878.5010
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 84 510(k) clearances via K numbers.

    K Number Device Name
    K233355 Cypris eXact Suturing System
    K230746 Non absorbable Surgical Polypropylene Suture
    K221280 Vesseal
    K211178 DURAMESH Mesh Suture
    K192953 APTOS Threads – Polypropylene Surgical Sutures
    K193530 Deklene MAXX
    K191299 Silhouette Featherlift / Silhouette Lift
    K173747 REXLENE
    K180321 Aesculap Optilene Nonabsorbable Suture
    K173644 Gazelle Polypropylene Suture and Delivery Device
    K171039 Assut Filbloc Permanent Sutures
    K171005 Silhouette Featherlift
    K162617 NobleStitch EL
    K160529 Pledgeted COR-SUTURE QUICK LOAD
    K143582 MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
    K151112 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design
    K141206 EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
    K142639 StitchKit
    K133890 AESCULAP OPTILENE NONABSORBABLE SUTURE
    K133356 PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
    K131224 SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
    K130078 QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    K113494 NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
    K113763 SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
    K113800 QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE
    K100593 SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
    K093112 DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
    K070243 SUTRALENE POLYPROPYLENE SUTURES
    K061700 NEOTRACT ANCHOR
    K060414 KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
    K062125 SUPERSTITCH 5F, 12F, AND EL
    K053482 SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW
    K052701 COROLENE
    K052962 OPTIMIZED BARB DESIGN
    K052373 QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
    K041511 TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
    K050947 MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
    K043330 POLYPROPILENE SURGICAL SUTURES
    K050548 CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
    K050247 CONTOUR NECKLIFT THREADS
    K043591 FEATHERLIFT EXTENDED APTOS THREAD
    K042856 CONTOUR FOREHEAD/BROWLIFT THREAD
    K042283 UNIPRO
    K041593 FEATHERLIFT EXTENDED LENGTH APTOS THREAD
    K021834 SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
    K020940 SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X
    K020265 SERRALENE, MODEL CATALOG NO 1S
    K013683 MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
    K012865 SUPERSTITCH VASCULAR SUTURING DEVICE
    K010990 AMS SLING FIXATION SYSTEM
    K010909 NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
    K002999 GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
    K002557 SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
    K001703 PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
    K002435 MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)
    K001625 PRONOVA NONABSORBABLE SUTURE, USP
    K001185 POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
    K000537 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
    K993997 POLYPROPYLENE
    K994313 MODIFICATION TO BONE ANCHOR AND KIT (BAK)
    K992405 AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)
    K983108 SUTURE WELDING SYSTEM AND KIT (SWK)
    K980703 PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
    K961389 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
    K961168 VIEWPOINT
    K960209 CPR HEART PACK
    K954808 USSC POLYPROPLENE SUTURE
    K953609 PRODEK
    K945701 SURGILENE(R) SUTURES
    K931917 SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE
    K931614 MOPYLEN SUTURE
    K930941 LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE
    K930587 SURGILENE POLYPROPYLENE SUTURE
    K926588 REVISED LABELING FOR POLYPROPYLENE SUTURE
    K922630 MOPYLEN
    K920437 SYNTHETIC ABSORBABLE SUTURE, UNDYED
    K914588 GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE
    K911905 DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED
    K903176 ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE
    K911189 STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
    K904906 SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP
    K903643 DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
    K903584 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
    K902872 NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*

    FEI Numbers

    This FDA classification entry is associated with 111 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 111 registration numbers. Click on an entry to view related FDA registrations.