FDA.reportPublic FDA data

C35-Curved scissor D3,5mm Sterile

Primary DI
E496C35ST2SCST1
Brand
C35-Curved scissor D3,5mm Sterile
Company
AB MEDICA
Model
C35-ST-2SC-ST
Catalog number
C35-ST-2SC-ST
Published
2020-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
E496C35ST2SCST10PrimaryHIBCC0
E496C35ST2SCST1Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260445203
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E496C05ADPTPDH0LUER LOCK Adaptor for pneumodissectorC05-ADPT-PDHC05-ADPT-PDH2026-07-08
E496C05HPDH0Handle for pneumodissection HookC05-H-PDHC05-H-PDH2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useC05-ID-CH-20-STC05-ID-CH-20-ST2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useC05-ID-CH-33-STC05-ID-CH-33-ST2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useC35-ID-CH-20-STC35-ID-CH-20-ST2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useC35-ID-CH-33-STC35-ID-CH-33-ST2026-06-08
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
E496C35IBDM330C35- Bipolar Maryland Insert L33cm D 3,5mmC35-IB-DM-33C35-IB-DM-332026-05-21
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

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Primary DI, Brand, Company table
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