Product code GAW— General, Plastic Surgery
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
- Classification name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class 2
- Regulation
- 21 CFR 878.5010
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 85
- First cleared
- Most recent
Market context for product code GAW
FDA has cleared devices under product code GAW between 1990 and 2026, filed by 56 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2024
- 2023
- 2022
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2010
- 2007
Top applicants under product code GAW
Adverse events under product code GAW
product code GAW- Death
- 66
- Injury
- 1,616
- Malfunction
- 10,428
- Total
- 12,110
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GAW
- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- 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
- K043591 — FEATHERLIFT EXTENDED APTOS THREAD
- K050247 — CONTOUR NECKLIFT THREADS
- 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
- K926588 — REVISED LABELING FOR POLYPROPYLENE SUTURE
- K930587 — SURGILENE POLYPROPYLENE SUTURE
- K930941 — LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE
- K931614 — MOPYLEN 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
- K903643 — DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
- K904906 — SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP
- K903584 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
- K902872 — NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*
Data sourced from openFDA. This site is unofficial and independent of the FDA.