FDA.reportPublic FDA data

C35- Bipolar Maryland Insert L33cm D 3,5mm

Primary DI
E496C35IBDM330
Brand
C35- Bipolar Maryland Insert L33cm D 3,5mm
Company
AB MEDICA
Model
C35-IB-DM-33
Catalog number
C35-IB-DM-33
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140101000ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARSAb Medica Sas2014-07-10GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E496C35IBDM330PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
260445203
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmC35-BTU-20C35-BTU-202026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmC35-IB-DM-20C35-IB-DM-202026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmC35-IB-FS-20C35-IB-FS-202026-05-28
E496C35SEAL11Disposable valve for trocar D=3,5mmC35-SEAL-1C35-SEAL-12020-03-03
E496C35SEAL31Disposable valve for trocar D=3,5mm (x3)C35-SEAL-3C35-SEAL-32020-03-03
E296LILSEAL11Disposable valves for trocar Ø 3 mmLIL-SEAL-12018-07-13
E296LILSEAL31Disposable valves for trocar Ø 3 mmLIL-SEAL-32018-07-19
E496LILIP2SC20ST0Low Impact™ Curved Scissors, Jaw Insert (sterile) L=20cm LIL-IP-2SC-20STLIL-IP-2SC-20ST2021-06-11
E496C35HH330C35-Hand Activated HOOK L=330mmC35-HH-33C35-HH-332021-07-23
E496COEC3501200REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=120MMCOEC350120COEC3501202021-07-23
E496COEC350600REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=60MMCOEC35060COEC350602021-07-23
E496COEC350750REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=75MMCOEC35075COEC350752021-07-23
E496COEC351000REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=100MMCOEC35100COEC351002021-07-23
E496C35IP2AL330C35-Allis Grasping Forceps, 2 mobile jaws Insert L=33mm D=3,5mmC35-IP-2AL-33C35-IP-2AL-332021-04-01
E496C35IP2BI330C35-Biopsy 2 mobile jaws insert L 33cm D 3,5mmC35-IP-2BI-33C35-IP-2BI-332021-04-01
E496C35IP2CL330C35-Clutch 2 mobile jaws insert L 33cm D 3,5mmC35-IP-2CL-33C35-IP-2CL-332021-04-01
E496C35IP2DC330"C35-""C"" Shape Dissector, Jaw Insert L=33mm D=3,5mm"C35-IP-2DC-33C35-IP-2DC-332021-04-01
E496C35IPS20330C35-20mm Tapered insert L 33cm D 3,5mmC35-IP-S20-33C35-IP-S20-332021-04-01
E496C35IPSM330C35- SEMM insert 1movable jaws L 33cm D 3,5mmC35-IP-SM-33C35-IP-SM-332021-04-01
E496C05NS350MicroLap Needle Driver - Straight L=35cm D=5mmC05-NS-352019-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210372LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210396LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210518LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210587LaportSejong Medical Co., LtdGCJ2018-04-05
08806182210877LaportSejong Medical Co., LtdGCJ2018-04-05
07613327311839Connect OR OSSTRYKER CORPORATIONGCJ2017-06-30
07613327311846Connected OR OSSTRYKER CORPORATIONGCJ2017-06-30
08719324463126symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463133symphonX™Fortimedix Surgical B.V.GCJ2017-02-15
08719324463140symphonX™Fortimedix Surgical B.V.GCJ2017-02-15