FDA.reportPublic FDA data

Myosure Reach Tissue Removal Device

Primary DI
15420045504530
Brand
Myosure Reach Tissue Removal Device
Company
Hologic, Inc.
Model
10-401FC
Catalog number
10-401FC
Device description
The MyoSure Tissue Removal System is intended for hysteroscopic intrauterine resection procedures by a trained gynecologist to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception.
Published
2023-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152723000Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.2015-11-13HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25420045504537PackageGS11In Commercial Distribution
35420045504534PackageGS13In Commercial Distribution
15420045504530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2542004550453725420045504537
3542004550453435420045504534
1542004550453015420045504530

GMDN Terms#

Term, Definition table
TermDefinition
Tissue morcellation systemAn assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
08714729986935Cytuity™BOSTON SCIENTIFIC CORPORATIONHIH2019-08-20
10884521750203TruClearCovidien LPHIH2018-12-21
00821925004986Gyrus ACMIGyrus ACMI, LLCHIH2018-09-13
10884521744080TruClearCovidien LPHIH2017-10-16
10884521744097TruClearCovidien LPHIH2017-10-16
10884521744103TruClearCovidien LPHIH2017-10-16
10884521744110TruClearCovidien LPHIH2017-10-16
M648C0100110SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN OBP CORPORATIONHIH2016-11-11
M648C0100120 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO OBP CORPORATIONHIH2016-11-11
00821925001862USA SeriesGyrus ACMI, LLCHIH2016-10-14