Atlas FDA

OTO

23 FDA 510(k) clearances · Product code

97 daysmedian time to decision
235 days90th percentile
23clearances measured

FDA profile

Official device name
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Flags
Implant
FDA definition
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
Adverse events (MAUDE)
2021: 292 · 2022: 112 · 2023: 101 · 2024: 113 · 2025: 81 · 2026: 44
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Polyform Synthetic Mesh (K171271)Boston Scientific Corporation2017-12-15
Vertessa Lite Y-Mesh (K150023)Caldera Medical, Inc.2015-04-06
Vertessa Lite (K150016)Caldera Medical, Inc.2015-04-06
RESTORELLE Y CONTOUR MESH (K140116)Coloplast A/S2014-02-12
RESTORELLE M, RESTORELLE XL (K132061)Coloplast Corp.2013-08-02
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH (K123028)Caldera Medical, Inc.2013-04-25
RESTORELLE Y CONTOUR (K123914)Coloplast A/S2013-03-05
VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM (K123337)Caldera Medical2013-02-21
UPSYLON Y MESH (K122794)Boston Scientific Corp2012-12-18
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 (K122968)Coloplast Corp.2012-12-18
RESTORELLE L (K122440)Coloplast Corp.2012-11-19
AMS LARGE PORE POLYPROPHLENE MESH (K121805)American Medical Systems2012-10-16
ARTISYN Y-SHAPED MESH (K113205)ETHICON, Inc.2012-06-11
RESTORELLE POLYPROPYLENE Y MESH (K112322)Coloplast A/S2012-05-17
VERTESSA (K120327)Caldera Medical, Inc.2012-05-10
ALYTE Y-MESH GRAFT (K101722)C.R. Bard, Inc.2011-04-01
BARD SACROCOLPOPEXY GRAFT (K090739)C.R. Bard, Inc.2009-11-10
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH (K053361)Mpathy Medical Devices, Ltd.2006-02-06
AMS PELVIC FLOOR REPAIR SYSTEM (K051485)American Medical Systems, Inc.2005-08-03
POLYFORM SYNTHETIC MESH (K051245)Proxy Biomedical , Ltd.2005-06-17
MINIMESH POLYPROPYLENE MESH (K041632)Mpathy Medical Devices, Ltd.2004-11-17
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR (K013718)Gynecare, A Div. of Ethicon, Inc.2002-01-08
AMS SACRAL COLPOPEXY SLING, MODEL 72403501 (K010931)American Medical Systems, Inc.2001-04-09

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Every clearance here is in the API, with alerts when new ones post.