FDA.reportPublic FDA data

Patel Pipelle

Primary DI
B296820010
Brand
Patel Pipelle
Company
TITUS MEDICAL LLC
Model
82001
Device description
Single unit
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HHKCurette, Suction, Endometrial (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHKCurette, Suction, Endometrial (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990387000ENDOMETRIAL SAMPLERU.A. Medical Products, Inc.1999-04-20HHK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B296820010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endometrial biopsy kitA collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080306309
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011427378Titus Medical LLCTM1187TM11872026-04-20
00850011427385TITUS MEDICALTM1197TM1197 WITH WIRE2026-04-19
00850011427200IMA HSG Catheters 61-5005 HSG61-5005 HSG2024-04-03
00850011427217IMA HSG Catheters 61-5005 HSG61-5005 HSG2024-04-03
00850011427187SonoInject Catheter HSG61-2005 HSG61-2005 HSG2024-03-31
00850011427194SonoInject Catheter HSG61-2005 HSG61-2005 HSG2024-03-31
B29606107X0Sonocath06-107X2017-01-20
B29606107X10Sonocath06-107X12017-01-20
B29606105X0Sonocath06-105X2017-01-20
B29606105X10Sonocath06-105X12017-01-20
B296C070709HSG CatheterC07072016-09-15
10850011427146HSG/SIS Trays/Kits with 5Fr catheter06-3052021-03-27
10850011427153HSG Trays/Kits 7fr06-3072021-03-27
B29606300010 HSG/SIS Procedure Trays 06-30006-3002021-03-27
B2960630011 HSG/SIS Tray No Catheter06-300 2021-03-27
B296063051HSG/SIS Tray/Kit with 5fr HSG Catheter 06-3052021-03-27
B296063071HSG/SIS Tray with 7fr Catheter06-3072021-03-27
B29606105X400Sonocath06-105X402017-01-20
B296063050HSG Trays 06-3052016-09-16
B296063070HSG Trays 06-3072016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974500612718Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612725Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612732Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612749Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612756Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612763Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612770Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612787Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612794Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612824Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612831Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612848Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612855Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612862Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612879Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612886Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612893Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500612909Rigid Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613333Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613340Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613357Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613364Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
06974500613371Flexible Uterine Aspiration CuretteGCMEDICA ENTERPRISE LTD.(WUXI)HHK2026-05-18
00810142352338Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
00810142352369Bioteque America, Inc.Bioteque America, Inc.HHK2025-05-08
04719894432335BiotequeBioteque Taiwan Ltd.HHK2024-12-06
00821925029231DISPOSA-TOPGyrus ACMI, LLCHHK2024-07-25
00821925000926Gyrus ACMIGyrus ACMI, LLCHHK2024-07-24
00821925000025VacuretteGyrus ACMI, LLCHHK2024-07-23
04719894433363BiotequeBioteque Taiwan Ltd.HHK2024-04-08