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Found 9 results
510(k) Data Aggregation
K Number
K142525Device Name
PK Lap Loop
Manufacturer
Olympus Winter & Ibe GmbH
Date Cleared
2014-11-21
(74 days)
Product Code
HIN
Regulation Number
884.4150Why did this record match?
Product Code :
HIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bipolar Laparoscopic Loop is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Olympus Electrosurgical Generator ESG-400.
Device Description
The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Olympus Electrosurgical Generator ESG-400. It is available in an 88mm x 227mm loop size. The device is sterilized by ethylene.
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K Number
K130305Device Name
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
Manufacturer
LINA MEDICAL APS
Date Cleared
2013-07-24
(169 days)
Product Code
HIN
Regulation Number
884.4150Why did this record match?
Product Code :
HIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical (subtotal) hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgical generator that provides a bipolar outlet.
Device Description
The LiNA Bipolar Loop is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; 160mm x 80mm, 200mm x 100mm x 120mm x 120mm. The outer 15mm on each side of the loop is not insulated i.e. the bipolar cutting area length totals 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet.
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K Number
K122983Device Name
KSEA BIPOLAR ELECTRODE
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2013-06-26
(273 days)
Product Code
HIN
Regulation Number
884.4150Why did this record match?
Product Code :
HIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Karl Storz Bipolar Electrode is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions and septa, and benign conditions requiring endometrial ablation. Procedures include:
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation
Device Description
The Karl Storz Bipolar Electrode is a single-use.cutting loop electrode that is designed to be used in combination with a 4 mm resectoscope with a 24 or 26 Fr sheath that is connected to a generator via a high frequency cable.
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K Number
K122605Device Name
PKS BILL
Manufacturer
GYRUS ACMI, INC.
Date Cleared
2012-12-05
(100 days)
Product Code
HIN
Regulation Number
884.4150Why did this record match?
Product Code :
HIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.
Device Description
The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the G400 generator. It is available in an 88mm x 227mm loop size. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10-6.
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K Number
K113080Device Name
TUBALGATOR
Manufacturer
MECTRA LABS, INC.
Date Cleared
2012-06-29
(255 days)
Product Code
HIN
Regulation Number
884.4150Why did this record match?
Product Code :
HIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K111751Device Name
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
Manufacturer
ETHICON, INC.
Date Cleared
2011-12-02
(163 days)
Product Code
HIN, HIH
Regulation Number
884.4150Why did this record match?
Product Code :
HIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation. Procedures include:
- . Excision of intrauterine myomas
- ◆ Excision of intrauterine polyps
- . Lysis of intrauterine adhesions
- Incision of uterine septa
- . Endometrial ablation
Device Description
The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System (VERSAPOINT II System) is the next generation of the currently-marketed GYNECARE VERSAPOINT™ Bipolar Electrosurgery System (VERSAPOINT System). This electrosurgical system utilizes bipolar technology specifically designed to provide a range of gynecological surgical treatments, including vaporization to ablate and excise tissue, thermal coagulation of tissue and hemostasis of blood vessels. The VERSAPOINT II System is comprised of four main elements: the VERSAPOINT II Generator, the VERSAPOINT II 4mm Angled Loop Electrode, the VERSAPOINT II Footswitch, and the VERSAPOINT II Connector Cable. The VERSAPOINT II System offers five bipolar output modes: Ablation (VC [VaporCut]) – for tissue removal and cutting Enhanced Ablation (VP [VersaPulse]) - an enhanced version of the Ablation (VC) output mode attained by use of short-duration high power pulses Blended Ablation (BL) – simultaneous ablation and coagulation (the generator rapidly switches between ablation and coagulation output modes) Enhanced Blended Ablation (VBL) – a variant of the VP output mode that rapidly switches the output ON and OFF to deliver blended ablation/coagulation Coagulation (DES [Desiccate]) - for thermal coagulation and hemostasis
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K Number
K111059Device Name
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
Manufacturer
GYRUS ACMI, INC.
Date Cleared
2011-09-01
(136 days)
Product Code
HIN
Regulation Number
884.4150Why did this record match?
Product Code :
HIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation/sectioning of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.
Device Description
The Bipolar Laparoscopic Loop (PKSTM BiLL™) is-a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Gyrus ACMI G400 Workstation Generator. The PKSTM BiLL™ is a laparoscopic instrument. It is available in an 88mm x 215mm loop. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10°0
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K Number
K990147Device Name
BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771
Manufacturer
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Date Cleared
1999-04-16
(87 days)
Product Code
HIN
Regulation Number
884.4150Why did this record match?
Product Code :
HIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization.
Device Description
The modular bipolar forcep set provides precise grasping and axial holding placement of the jaws, performs thorough hygiene, and site irrigation can be achieved without using additional instruments.
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K Number
K971565Device Name
BICOAG COAGULATING FORCEPS
Manufacturer
EVEREST MEDICAL CORP.
Date Cleared
1998-03-12
(317 days)
Product Code
HIN
Regulation Number
884.4150Why did this record match?
Product Code :
HIN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. Laparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.
Device Description
The device is a Class III medical device. The Tubal Sterilization device is similar to Everest Medical's current laparoscopic BiCOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps.
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