FDA.report

Product code KGZ

Current FDA Classification

Device name
Accessories, Catheter
Medical specialty
General, Plastic Surgery
Device class
1
Regulation number
878.4200
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K022306AART SILICONE TUBINGAesthetic and Reconstructive Technologies, Inc.2002-10-10
K974295BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBINGByron Medical1998-02-10
K973183WOUND DRAINAGE HOLDERR & D Medical Products, Inc.1998-01-23
K955433DURALASTIC SILICONE TUBINGAllied Biomedical Corp.1996-01-26
K942315NAVARRE PERCUTANEOUS ACCESS SETNavarre Biomedical , Ltd.1994-07-08
K896087PALESTRANT IRRIGATION AND DRAINAGE SETNorth American Instrument Corp.1989-11-03
K895041OPTICAL CATHETER(TM) INTRODUCER SETSMedical Dynamics, Inc.1989-10-16
K893406DESERET PRN ADAPTERDeseret Medical, Inc.1989-06-22
K873009CONCEPT SWITCHING STICKConcept, Inc.1987-08-17
K870014HCI GENERAL PURPOSE CATHETER STYLETHealth Care Innovations, Inc.1987-02-06
K864115TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SUCathaid, Inc.1986-11-07
K855078ANGIO MED DISPOSABLE PRESSURE CONNECTORSAngiomed U.S., Inc.1986-02-19
K842666NU-THOR THORACOSTOMY KITIntl. Medical Devices , Ltd.1984-09-20
K821525DESERET UNIVERSAL LUER LOCKWarner-Lambert Co.1982-06-23
K821245DESERET OFFSET PRN ADAPTERWarner-Lambert Co.1982-05-13
K810531PERI-PATCH PERITONEAL CATHETER EXTENSIONQuinton, Inc.1981-03-24
K810530PERI-PATCH GLUE MOLDQuinton, Inc.1981-03-24
K802367ARROW CATHETER CLAMPArrow Intl., Inc.1980-10-23
K802286ARGLE LATEX PENROSE TUBINGSherwood Medical Co.1980-10-23
K791806CONPHAR ADAPT-CONNECTS STERILE, NONSTE.Conphar, Inc.1979-09-21
K791803CONPHAR CATHETER PLUGConphar, Inc.1979-09-21
K790597SENSOMAT SIDEARM ADAPTERBiochem International, Inc.1979-07-10
K781846ADAPTER, CATHETER SHEATHArrow Intl., Inc.1978-12-12
K781854PAD, B-D I.V. CATH.Bd Becton Dickinson Vacutainer Systems Preanalytic1978-12-04
K780259CATHETERIZATION TRAY & KITArgon Medical Corp.1978-04-18
K7701543-WAY STOPCOCK WITH LUER-LOCK FITTINGAmerican Viggo1977-02-28
K760385EXTENSION SETSB. Braun Instruments1976-11-02
K760384STOPPERSB. Braun Instruments1976-11-02
K760383STOPCOCKSB. Braun Instruments1976-11-02

Related GUDID Devices

Primary DIBrandCompanyPublished
20653160392375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.2026-02-26
06937440443811YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.2025-12-09
06937440443828YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.2025-12-09
40198459435202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.2025-07-21
40704411017883AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.2025-06-23
04048223118702FixoLongPajunk GmbH Medizintechnologie2025-04-04
05708932767811SopranoColoplast A/S2025-03-26
20192253053606DevonCardinal Health 200, LLC2025-03-25
20192253042020DevonCardinal Health 200, LLC2025-03-07
20192253042037DevonCardinal Health 200, LLC2025-03-07
00840306835124Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.2024-12-10
00812269030625Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030601Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030588Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030564Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030540Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030526Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030502Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030489Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030465Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030441Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030427Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030380Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030366Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030342Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
00812269030311Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
10810050852293Typenex Wound DrainageTYPENEX MEDICAL LLC2022-11-15
10810050853740Typenex Wound DrainageTYPENEX MEDICAL LLC2021-08-13
10810050853733Typenex Wound DrainageTYPENEX MEDICAL LLC2021-08-13
20884521139845DevonCardinal Health, Inc.2018-06-29