Search Results
Found 4 results
510(k) Data Aggregation
K Number
K012277Device Name
PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
Manufacturer
SIMS PORTEX LTD.
Date Cleared
2002-02-11
(207 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.
Device Description
A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending.
Ask a Question
K Number
K012068Device Name
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
Manufacturer
SIMS PORTEX LTD.
Date Cleared
2001-08-03
(32 days)
Product Code
MQE
Regulation Number
884.6100Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles.
The Wallace Oocyte Retrieval Sets are sterile, single-use intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.
Device Description
Wallace Oocyte Retrieval Set is a single-use device provided sterile for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The set consists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex) tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is 33cm in length and available in 16 gauge or 17 gauge, each having echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Tubing is attached to the hub of the needle and protrudes a total distance of 700mm until it passes through a silicone bung and terminates in an ABS female luer connector. FEP tubing for suction also protrudes through the bung, and at the other end terminates in a polypropylene luer lock connector.
Ask a Question
K Number
K001555Device Name
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
Manufacturer
SIMS PORTEX LTD.
Date Cleared
2000-08-02
(76 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K000628Device Name
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
Manufacturer
SIMS PORTEX LTD.
Date Cleared
2000-03-13
(18 days)
Product Code
MQE
Regulation Number
884.6100Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1