FDA.reportPublic FDA data

Athena Surgical RMUS System

Primary DI
00860003619803
Brand
Athena Surgical RMUS System
Company
Athena Surgical LLC
Model
9003
Device description
Instrument Handle
Published
2021-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210087000Athena Surgical RMUS SystemAthena Surgical, LLC2021-04-12OTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90860003619837PackageGS13In Commercial Distribution
00860003619803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
9086000361983790860003619837
00860003619803008600036198038600036198030860003619803

GMDN Terms#

Term, Definition table
TermDefinition
Stress urinary incontinence surgical mesh, femaleA sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may be referred to as a sling, tape, or subfascial hammock, and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., needles, sheaths) may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117067792
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003619810Athena Surgical RMUS System9001-12021-07-30
00860003619827Athena Surgical RMUS System9002-12021-07-30
20860003619814Athena Surgical RMUS System9001-12021-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890594000124Desara Blue TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000131Desara TVez 2.7Caldera Medical, Inc.OTN2022-08-03
00890594000155Desara TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000193Desara Blue TVez 2.7Caldera Medical, Inc.OTN2022-08-03
00890594000087Desara Blue TVez 3.0Caldera Medical, Inc.OTN2021-11-15
00890594000094Desara Blue TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000100Desara TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000117Desara TVez 3.0Caldera Medical, Inc.OTN2021-11-15
00191506007652Advantage Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00191506007669Advantage Fit Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00191506007676Lynx Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00860003619810Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
20860003619814Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
00860003619827Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
08437007606027Remeex System (for Female Urinary Incontinence)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606065KIM (Knotless Incontinence Mesh)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606072Remeex System -Readjustment kit DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606263Remeex System - Thread PasserDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606683KIM (Knotless Incontinence Mesh)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606836Remeex System - Passer Handle DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
00890594000858Desara Blue TVCaldera Medical, Inc.OTN2019-09-30
00890594000896DesaraCaldera Medical, Inc.OTN2019-09-30
00890594000902Desara TV Caldera Medical, Inc.OTN2019-09-30
00890594000841Desara Blue TVCALDERA MEDICAL, INC.OTN2019-09-30
00890594000889DesaraCALDERA MEDICAL, INC.OTN2019-09-30
00890594000919Desara TV CALDERA MEDICAL, INC.OTN2019-09-30
00860368002401ArcTV™ Transvaginal Sling SystemUROCURE LLCOTN2019-08-13
08714729961918Advantage™ Blue SystemBOSTON SCIENTIFIC CORPORATIONOTN2018-01-22
08714729961925Advantage Fit™ Blue SystemBOSTON SCIENTIFIC CORPORATIONOTN2018-01-22
08714729961932Lynx™ Blue SystemBOSTON SCIENTIFIC CORPORATIONOTN2018-01-22