FDA.reportPublic FDA data

Emmett Tenaculum

Primary DI
GYNX32200
Brand
Emmett Tenaculum
Company
GYNEX CORPORATION
Model
3220
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HDCTenaculum, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDCTenaculum, UterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980247000GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUMGynex Corp.1998-03-17HDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GYNX32200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Uterine fibroid hookA shaft-like surgical instrument whose distal end tapers to form a hook or multiple hooks used to fix or apply traction to uterine fibroids during a gynaecological procedure. It is typically a one-piece instrument made of high-grade stainless steel with a handle at the proximal end that is available in various shapes. In multiple hook designs, the hooks are in parallel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012997685
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GYNX32500Gynex32502023-12-13
GYNX32550Gynex32552023-12-13
GYNX80091Gynex80092023-12-19
GYNX80241Gynex80242023-12-19
GYNX80721Gynex80722023-12-19
GYNX81001Gynex81002023-12-19
GYNX81031Gynex81032023-12-19
GYNX82001Gynex82002023-12-19
GYNX292001Gynex29-2002023-12-26
GYNX293001Gynex29-3002023-12-26
GYNX298501Gynex29-8502023-12-26
GYNX31301Gynex31302023-12-26
GYNX31351Gynex31352023-12-26
GYNX32071Gynex32052023-12-26
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071684162Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684179Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684186Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684193Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684209Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684216Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00850071684223Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
00860012999606Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDC2025-01-21
04046955057191AESCULAPAESCULAP, INC.HDC2020-10-19
00304040015971Henry ScheinHENRY SCHEIN, INC.HDC2018-10-17
GYNXLT22500LLETZ Braun TenaculumGYNEX CORPORATIONHDC2017-01-19
10381780177616Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDC2016-12-29
10381780176800Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDC2016-12-29
10612479141961McKessonMCKESSON MEDICAL-SURGICAL INC.HDC2016-12-09
10612479143606McKessonMCKESSON MEDICAL-SURGICAL INC.HDC2016-12-09
GYNX32100Iris HookGYNEX CORPORATIONHDC2016-10-10
GYNX32250Angle HookGYNEX CORPORATIONHDC2016-10-10
GYNX322702-Prong HookGYNEX CORPORATIONHDC2016-10-10
GYNX322903-Prong HookGYNEX CORPORATIONHDC2016-10-10
GYNX32300LLETZ Iris HookGYNEX CORPORATIONHDC2016-10-10
GYNX32400LLETZ Emmett TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX32450LLETZ Angle HookGYNEX CORPORATIONHDC2016-10-10
GYNX32490LLETZ Braun Standard TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX35000Schroeder TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX35010Schroeder Tenaculum, Double ToothGYNEX CORPORATIONHDC2016-10-10
GYNX35020Braun TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX35300Schroeder Tenaculum, AngledGYNEX CORPORATIONHDC2016-10-10
GYNX35320Braun Tenaculum, AngledGYNEX CORPORATIONHDC2016-10-10
GYNX35340Skeane Tenaculum, Slight CurveGYNEX CORPORATIONHDC2016-10-10
GYNX35360Teale Tenaculum, Slight CurveGYNEX CORPORATIONHDC2016-10-10