FDA.reportPublic FDA data

MicroLap Knot Pusher 200mm

Primary DI
E496LILKG200
Brand
MicroLap Knot Pusher 200mm
Company
AB MEDICA
Model
LIL-KG-20
Published
2018-07-13
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
E496LILKG200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suture knot pusher, reusableA hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
260445203
Device count
1
Lot or batch
true
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
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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