FDA.reportPublic FDA data

Y-TEC®

Primary DI
00884450170120
Brand
Y-TEC®
Company
Merit Medical Systems, Inc.
Model
00884450170120
Catalog number
FS-300/A
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K823295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823295000MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&Medigroup1983-05-06HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450170120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450170120008844501701208844501701200884450170120

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450029695Merit Medical®Initial ReleaseK08-02207A2026-07-24
00884450383865Merit Medical®Initial ReleaseK10-01245L2026-07-25
00884450419922SureCrossDSC181352026-07-24
00884450428320Merit Medical®Initial ReleaseK09-10593C2026-07-24
00884450470831Merit Medical®Initial ReleaseK09-12157A2026-07-24
00884450484203Merit Medical®Initial ReleaseK09-144012026-07-24
00884450485569Merit Medical®Initial ReleaseK12T-127302026-07-24
00884450486214Merit Medical®Initial ReleaseK12T-12593A2026-07-24
00884450486955Merit Medical®Initial ReleaseK02-016512026-07-25
00884450545010Aspira®Initial Release49925242026-07-25
00884450545034Aspira®Initial Release4992524B2026-07-25
00884450793817BioFlo DuraMax®AH9651030380112026-07-25
00884450846148Merit Medical®Initial ReleaseK09-14237A2026-07-25
00884450433812Merit Medical®Initial ReleaseK08-02803A2026-07-23
00884450485163Merit Medical®Initial ReleaseK12T-11888B2026-07-23
00884450376546Merit Medical®Initial ReleaseK09-05229L2026-07-22
00884450431764Merit Medical®Initial ReleaseK10-04836A2026-07-22
00884450488751Merit Medical®Initial ReleaseK09-144102026-07-22
00884450492888Merit Medical®Initial ReleaseK01-08008A2026-07-22
00884450499276Merit Medical®Initial ReleaseK09-13679B2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817401029178EndoplusEndoplusHET2026-07-08
00198506091452ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00198506091469ELMED INCORPORATEDELMED INCORPORATEDHET2026-06-05
00817401029161EndoplusEndoplusHET2026-06-05
10653405044703CORE DYNAMICSConmed CorporationHET2026-03-23
10887482155261Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155285Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155308Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10887482155322Symmetry Secto®ASPEN SURGICAL PRODUCTS, INC.HET2024-09-09
10381780538608Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538622Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538646Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538660Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538677Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538691Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538707Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538714Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538721Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538776MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538783MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538790Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538806Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538813Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538837MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538844MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538851Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538899Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538905Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538936Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29
10381780538943Integra® MicroFrance®INTEGRA MICROFRANCEHET2024-05-29