FDA.reportPublic FDA data

ALLY II UPS (Uterine Positioning System)

Primary DI
00888937029697
Brand
ALLY II UPS (Uterine Positioning System)
Company
Coopersurgical, Inc.
Model
AU-UPS2-RNTL
Device description
ALLY II UPS (Uterine Positioning System)
Published
2025-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223064000ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc.2022-10-28LKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888937029697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888937029697008889370296978889370296970888937029697

GMDN Terms#

Term, Definition table
TermDefinition
Uterine manipulator, reusableA hand-held, manually-operated, surgical instrument designed to mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopic hysterectomy), to enable uterine control and improved visibility of the pelvic anatomy. The device typically consists of a probe which is positioned within an introduction sheath/handpiece and includes an illuminator for transillumination of the uterus/cervix during laparoscopy (through the diaphanoscopy effect); it typically includes a suction line (for aspiration and/or tissue retention/manipulation). This is a reusable device intended to be sterilized prior to use.

Regulatory Flags#

DUNS number
801895244
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937027327ER-SpecC0203002026-08-05
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06
00888937027457ER-SpecC020130-12026-08-06
00888937027464ER-SpecC020140-12026-08-06
00888937027594AnoSPECC0601002026-08-05
00888937027600AnoSPECC0601102026-08-05
00888937027617AnoSPECC0601202026-08-05
00888937032833LifeGlobal® Coda®Incubator UnitGCIU-010-M2026-08-03
00888937032840LifeGlobal® Coda®Filter for Incubator UnitGCIF-001-M2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011716853Monarch Medical ProductsBioteque Taiwan Ltd.LKF2026-07-24
04719894436456LTL MedicalBioteque Taiwan Ltd.LKF2026-07-24
04719894436463LTL MedicalBioteque Taiwan Ltd.LKF2026-07-24
04719894436470LTL MedicalBioteque Taiwan Ltd.LKF2026-07-24
M803003276512Uterine ManipulatorMEDGYN PRODUCTS, INC.LKF2026-06-08
M803003276515Uterine ManipulatorMEDGYN PRODUCTS, INC.LKF2026-06-08
00850011427378Titus Medical LLCTITUS MEDICAL LLCLKF2026-04-20
00850011427385TITUS MEDICALTITUS MEDICAL LLCLKF2026-04-19
20859500005008FemVueFEMASYS INC.LKF2026-01-06
30859500005005FemVueFEMASYS INC.LKF2026-01-06
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
00198506017704ELMED INCORPORATEDELMED INCORPORATEDLKF2025-07-08
00860010540930Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
10860010540937Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
00840306835360Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
04719894432892BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432908BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432915BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432922BiotequeBioteque Taiwan Ltd.LKF2024-12-06
00840306826177Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
00840306826184Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
04719894432571BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432588BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432595BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432601BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432618BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432625BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432755BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432762BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432779BiotequeBioteque Taiwan Ltd.LKF2024-04-08