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510(k) Data Aggregation
K Number
K243821Device Name
i-Cut
Manufacturer
A.M.I. Agency for Medical Innovations GmbH
Date Cleared
2025-04-25
(134 days)
Product Code
HET
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
Agency for Medical Innovations GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.
Device Description
The i-Cut is a single use laparoscopic power morcellator. It is provided sterile.
The i-Cut consists of a rotating cutting tube with a trocar that provides protection against the cutting blade when locked in the "CLOSED" position. The device comes with an obturator for placement into the patient's body and a locking clip that keeps the trocar in the "closed" position during insertion. The activation button must be pressed to cut tissue.
The lumen of the device is designed for use with a standard grasper or Tenaculum forceps with a diameter between 10 to 14 mm. The i-Cut is designed to be used with surgical instruments of diameters between 10 to 14 mm. The lumen is fitted with a silicone valve to prevent gas loss during use of the device.
The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
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K Number
K212659Device Name
More-Cell-System
Manufacturer
Agency for Medical Innovations GmbH
Date Cleared
2021-11-10
(79 days)
Product Code
PMU
Regulation Number
884.4050Why did this record match?
Applicant Name (Manufacturer) :
Agency for Medical Innovations GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
When used in women with fibroids, the More-Cell System is for women who are pre-menopausal and under age 50. More-Cell-System is compatible with electromechanical laparoscopic power morcellators that are between 12 mm and 20 mm in shaft outer diameter and between 95 mm and 170 mm in shaft working length.
Device Description
The More-Cell-System device is used as a receptacle for collection and extraction of tissue during laparoscopic surgical procedures (e.g., hysterectomy and myomectomy). The key components of the device include the following:
- A. More-Cell Bag: A single use, insufflatable, transparent, EO sterilized bag made of 50 µm thick polyurethane film that is biocompatible and cell-tight. The bag includes printed lines to aid in visualization during surgery. There are two openings to the bag: one opening that is 16 cm in diameter where a morcellator can be inserted (and where tissue can be removed), and a second opening that is 16 mm in diameter x 190 mm in length where a laparoscope can be inserted to visualize the surgical procedure. The bag capacity is 2.5 L (340 x 250 mm).
- B. Visi-Shield: A metal sleeve with a polycarbonate window for lens protection (comes in 0° or 30° angle) that is cell-tight to protect the laparoscopic camera during a surgical procedure. Using the Visi-Shield the surgical procedure can be visualized without compromising the integrity of the bag, laparoscopic view, or safety of the laparoscopic camera.
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K Number
K182013Device Name
EasyInstruments
Manufacturer
Agency for Medical Innovations GmbH
Date Cleared
2019-03-11
(227 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Agency for Medical Innovations GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Easylnstruments are indicated for cutting, grasping, dissecting and coagulation of tissue in laparoscopic surgical procedures.
Device Description
The A.M.I. EasyInstruments device is a modular instrument system for use in laparoscopic highfrequency (HF) surgery and is designed for monopolar application. The Easylnstruments system comprises three-part detachable instruments, which include 1) different functional handles (EasyHandle), 2) instrument shafts of various diameters and lengths (EasyShaft), and 3) a wide range of different, application-specific attachments (EasyTips). It is intended during laparoscopic procedures to mobilize, manipulate, grasp, hold, fix, retract, dissect, cut, and coagulate tissue.
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K Number
K182664Device Name
FiXcision
Manufacturer
Agency for Medical Innovations GmbH
Date Cleared
2018-12-07
(73 days)
Product Code
KOA
Regulation Number
876.4730Why did this record match?
Applicant Name (Manufacturer) :
Agency for Medical Innovations GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae.
Device Description
FiXcision is an EO-sterilized, single use, multi-part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae. The four components include the following:
- Probe: Component made of stainless steel that passes through the fistula tract.
- Guide: Component made of stainless steel that compresses tissue within the fistula tract.
- Base Plate: Component made of stainless steel that acts as a stop for the Circular Cutter.
- Circular Cutter: Component made of stainless steel and polyvinyl chloride (PVC-U). The Circular Cutter cuts tissue from fistula tract. The distal end of the Circular Cutter has a protective cap made of silicone that is removed prior to use.
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K Number
K150718Device Name
Wi-3 HAL-RAR System
Manufacturer
AGENCY FOR MEDICAL INNOVATIONS GMBH
Date Cleared
2015-06-12
(85 days)
Product Code
FHN, IYN
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
AGENCY FOR MEDICAL INNOVATIONS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.
Device Description
The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary. "HAL" is an acronym referring to "Hemorrhoidal Arteries Ligation", and "RAR" is an acronym referring to "Recto Anal Repair." The Wi-3 HAL-RAR System is designed for use in a surgical suite or operating room.
The Wi-3 HAL-RAR System includes components that come in contact with the patient during use. The RAR Probes (made of acrylic-based multipolymer) and Sleeve (PBT) are external communicating devices having limited contact duration (< 24 hours) with tissue. The Wi-3 Arm (made of Aluminum Alloy) and Wi-3 Fixation Nut (made of polyphenylsulfone and acetal) are surface devices having limited contact duration (< 24 hours) with skin.
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