Product code OTO— General, Plastic Surgery

“Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.”

FDA has cleared 23 devices under product code OTO between 2001 and 2017, filed by 13 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.

• 20171 clearance
• 20152 clearances
• 20141 clearance
• 20134 clearances
• 20127 clearances
• 20111 clearance
• 20091 clearance
• 20061 clearance
• 20052 clearances
• 20041 clearance
• 20021 clearance
• 20011 clearance

• Caldera Medical, Inc.4 clearances
• Coloplast Corp.3 clearances
• Coloplast A/S3 clearances
• Mpathy Medical Devices, Ltd.2 clearances
• C.R. Bard, Inc.2 clearances
• American Medical Systems, Inc.2 clearances
• Proxy Biomedical , Ltd.1 clearance
• Gynecare, A Div. of Ethicon, Inc.1 clearance
• ETHICON, Inc.1 clearance
• Caldera Medical1 clearance

Injury

840

Total

840

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K171271 — Polyform Synthetic MeshBoston Scientific Corporation·2017-12-15
• K150016 — Vertessa LiteCaldera Medical, Inc.·2015-04-06
• K150023 — Vertessa Lite Y-MeshCaldera Medical, Inc.·2015-04-06
• K140116 — RESTORELLE Y CONTOUR MESHColoplast A/S·2014-02-12
• K132061 — RESTORELLE M, RESTORELLE XLColoplast Corp.·2013-08-02
• K123028 — VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESHCaldera Medical, Inc.·2013-04-25
• K123914 — RESTORELLE Y CONTOURColoplast A/S·2013-03-05
• K123337 — VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMCaldera Medical·2013-02-21
• K122794 — UPSYLON Y MESHBoston Scientific Corp·2012-12-18
• K122968 — NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015Coloplast Corp.·2012-12-18
• K122440 — RESTORELLE LColoplast Corp.·2012-11-19
• K121805 — AMS LARGE PORE POLYPROPHLENE MESHAmerican Medical Systems·2012-10-16
• K113205 — ARTISYN Y-SHAPED MESHETHICON, Inc.·2012-06-11
• K112322 — RESTORELLE POLYPROPYLENE Y MESHColoplast A/S·2012-05-17
• K120327 — VERTESSACaldera Medical, Inc.·2012-05-10
• K101722 — ALYTE Y-MESH GRAFTC.R. Bard, Inc.·2011-04-01
• K090739 — BARD SACROCOLPOPEXY GRAFTC.R. Bard, Inc.·2009-11-10
• K053361 — MODIFICATION TO: MINIMESH POLYPROPYLENE MESHMpathy Medical Devices, Ltd.·2006-02-06
• K051485 — AMS PELVIC FLOOR REPAIR SYSTEMAmerican Medical Systems, Inc.·2005-08-03
• K051245 — POLYFORM SYNTHETIC MESHProxy Biomedical , Ltd.·2005-06-17
• K041632 — MINIMESH POLYPROPYLENE MESHMpathy Medical Devices, Ltd.·2004-11-17
• K013718 — GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIRGynecare, A Div. of Ethicon, Inc.·2002-01-08
• K010931 — AMS SACRAL COLPOPEXY SLING, MODEL 72403501American Medical Systems, Inc.·2001-04-09