FDA.reportPublic FDA data

GTK

Primary DI
06937845500614
Brand
GTK
Company
Guangzhou T.K Medical Instrument Co.,Ltd.
Model
VN-150
Published
2024-05-23
Public version status
Update
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
FHOPneumoperitoneum Needle
HIFInsufflator, Laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHOPneumoperitoneum NeedleGastroenterology, Urology2
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193339000GTK Veress NeedlesGuangzhou T.K Medical Instrument Co., Ltd.2020-01-30HIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06937845500614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937845500614069378455006146937845500614

GMDN Terms#

Term, Definition table
TermDefinition
Spring-loaded pneumoperitoneum needle, single-useA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
546374737
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937845501789GTK TROCARSCT Bladeless Trocar2026-04-27
06937845501796GTK TROCARSCT Optical Trocar2026-04-27
06937845501802GTK TROCARSCT Optical Trocar2026-04-27
06937845501819GTK TROCARSCT Optical Trocar2026-04-27
06937845501826GTK TROCARSCT Bladeless Trocar2026-04-27
06937845501833GTK TROCARSCT Bladed Trocar2026-04-27
06937845501840GTK TROCARSCT Bladed Trocar2026-04-27
06937845501857GTK TROCARSCT Bladed Trocar2026-04-27
06937845502274GTK TROCARSCT Bladeless Trocar2026-04-27
06937845502281GTK TROCARSCT Bladeless Trocar2026-04-27
06937845503639GTK TROCARSCT Bladeless Trocar2026-04-27
06937845503844GTK TROCARSCT Bladeless Trocar2026-04-27
06937845500607GTKVN-1202024-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955813360AESCULAPAesculap AGHIF2025-12-02
B3543000011ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000012ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000013ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000014ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000015ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000019ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
B3543000010ThoraClear Y ConnectorORANGE SURGICAL INSTRUMENTS, LLCHIF2025-11-25
04046955813353AESCULAPAesculap AGHIF2025-05-18
04055207007822NARichard Wolf GmbHHIF2024-08-19
04055207008393NARichard Wolf GmbHHIF2024-08-19
04055207058985NARichard Wolf GmbHHIF2024-08-19
10845854045633AIRSEALConmed CorporationHIF2024-03-27
00886874120699NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
B354OSLPCDG1Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG2Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG3Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG4Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG5Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG51Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG9Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
B354OSLPCDG0Lap-port closure device guides 5mm and 10/12 mmORANGE SURGICAL INSTRUMENTS, LLCHIF2024-03-07
00850059707005AccuMedxAccumedx, LLCHIF2024-01-23
00850059707012AccuMedxAccumedx, LLCHIF2024-01-23
10845854045367CONMEDConmed CorporationHIF2023-12-04
00810143450545MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpFHO2023-07-31
00810143450750MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpFHO2023-07-31
09420012433978Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
10850082007186Filter AssemblyARMM INC.HIF2023-06-08
10850082007193Insufflator Filter AssemblyARMM INC.HIF2023-06-08