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510(k) Data Aggregation
K Number
K992544Device Name
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
Manufacturer
CIRCON CORP.
Date Cleared
1999-10-26
(88 days)
Product Code
HEX
Regulation Number
884.1630Why did this record match?
Applicant Name (Manufacturer) :
CIRCON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Circon's Rigid Operative Culdoscopy Accessories are intended to be used with Circon's Rigid Culdoscope and Accessories for viewing pelvic organs endoscopically via a posterior vaginal fornix entry for the purpose of performing diagnostic and operative procedures on the female genital organs. Indications for use are:
- Unexplained pelvic pain (acute, chronic)
- Menstrual abnormalities
- Infertility and sterility
- Indefinite pelvic mass
- Ectopic pregnancy
- Pelvic endometriosis
- Polycystic ovaries
- Pelvic inflammatory disease (PID)
- Pain mapping
- Congenital anomalies of the pelvic organs
- Lysis of adhesions
- Cytology sampling
- Biopsy
Device Description
Circon's Rigid Operative Culdoscopy Accessories consist of several tubular stainless steel components. During culdoscopy, light from a high intensity light source is transmitted to a rigid culdoscope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the evepiece, or the scope may be connected to a video system via a standard endoscopic video coupler. In order to perform operative procedures, the operative cannula of the subject system replaces the smaller diagnostic cannula of the predicate system, and an operative sheath replaces the smaller diagnostic sheath of the predicate system. A channel is formed between the culdoscope and the operative sheath, thereby allowing passage of small instruments for a variety of operative procedures.
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K Number
K992126Device Name
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
Manufacturer
CIRCON CORP.
Date Cleared
1999-08-03
(41 days)
Product Code
GCX
Regulation Number
880.6740Why did this record match?
Applicant Name (Manufacturer) :
CIRCON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Circon Corporation's Tsunami™ Battery-Powered Irrigation Pump is intended to be used in conjunction with Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage.
Device Description
The Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is comprised of a Tsunami™ Battery-Powered Pump that may be attached to a source of irrigation tubing connected to a Surgiflex WAVE suction-irrigation handpiece, and a length of suction tubing connected between the handpiece and a vacuum source (usually a suction canister that is connected to a wall suction outlet). Irrigation solution is introduced to the surgical site and fluids, debris and smoke are evacuated from the site via a disposable suction-irrigation probe. All components of the system are supplied sterile, disposable in a sealed plastic tray for single patient use.
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K Number
K981611Device Name
SNAP-N-PEEL INTRODUCERS
Manufacturer
CIRCON CORP.
Date Cleared
1998-07-30
(85 days)
Product Code
KNY
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
CIRCON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CIRCON SURGITEK's Snap-N-Pee!™ Introducers are intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g., nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.
Device Description
The CIRCON SURGITEK Snap-N-Peel7M Introducer consists of a stepped dilator (with proximal Luer hub) that fits within an external sheath (with rotating locking collar). The dilator may be straight or curved and has a lumen to allow passage of fluids or a guidewire.
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K Number
K980972Device Name
RIGID CULDOSCOPE AND ACCESSORIES
Manufacturer
CIRCON CORP.
Date Cleared
1998-06-12
(88 days)
Product Code
HEW
Regulation Number
884.1640Why did this record match?
Applicant Name (Manufacturer) :
CIRCON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Circon's Rigid Culdoscopes and Accessories are intended for viewing pelvic organs endoscopically via a posterior vaginal fornix entry. Culdoscopy is indicated for: Unexplained pelvic pain (acute, chronic), Menstrual abnormalities, Infertility and sterility, Indefinite pelvic mass, Ectopic pregnancy, Pelvic endometriosis, Polycystic ovaries, Pelvic inflammatory disease, Pain mapping, Congenital anomalies of the pelvic organs.
Device Description
CIRCON's Rigid Culdoscopes and Accessories are rod lens-type endoscopes which consist of imaging optics and fiber optic illumination fibers contained within a stainless steel sleeve. Light from a high intensity light source is transmitted to the scope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.
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K Number
K973820Device Name
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
Manufacturer
CIRCON CORP.
Date Cleared
1998-05-12
(217 days)
Product Code
FAS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
CIRCON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Circon ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.
Device Description
CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are electrosurgical electrodes used in CIRCON ACMI's resectoscopes utilizing a direct connection between the electrode and the active cord of the electrosurgical generator.
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K Number
K964594Device Name
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)
Manufacturer
CIRCON CORP.
Date Cleared
1997-08-15
(273 days)
Product Code
KNF
Regulation Number
884.4160Why did this record match?
Applicant Name (Manufacturer) :
CIRCON CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The primary indications for use are abnormal uterine bleeding with or without pain, and infertility. Vaporization electrodes intended uses in gynecology, along with other resectoscopic electrodes and instruments, are: transuterine resection of fibroids, endometrial ablation, resectoscopic management of Müllerian fusion defects, resectoscopic management of intrauterine lesions, resectoscopic management of intractable uterine bleeding.
Device Description
VaporTrode™ Vaporization Electrodes in Gynecology
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