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510(k) Data Aggregation
K Number
K021224Device Name
ENDOCERVICAL BLOCK NEEDLE
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
2002-07-12
(86 days)
Product Code
HEE, FMI
Regulation Number
884.5100Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, CO2 laser excision, and vaporization, and when required, endocervical curettage and cervical biopsies.
Device Description
The Wallach Endocervical Block Needle is a Sterile, Disposable, Single Use device. The needle is 27ga., 3 1/2" long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intra-vascular administration set. Over 3 1/4" of its proximal end a 21 gauge metal tube is added to strengthen the shaft.
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K Number
K020711Device Name
WALLACH LOOP ELECTRODE
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
2002-06-03
(90 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used to excise target tissue, perform biopsies and control bleeding through a standard Monopolar Electrosurgical Generator.
Device Description
The Wallach LOOP Electrode is a Sterile, Disposable, Single Use Electrode. Used in conjunction with an ESU (electrosurtical unit or generator) to CUT or COAG during an electorsurgical procedure.
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K Number
K000768Device Name
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
2000-04-11
(33 days)
Product Code
EKZ
Regulation Number
872.4920Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992736Device Name
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
1999-09-29
(47 days)
Product Code
HIB
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wallach Ultimate Reusable, Plastic Vaginal Speculum is intended to be used for general gynecologic and electrosurgical procedures and is inserted into the vagina to expose the cervix. It is supplied non-sterile and is intended to be autoclavable for 100+ cycles.
Device Description
The Ultimate Reusable, Plastic Vaginal Speculum is a device used to expose the interior of the vagina during general gynecologic and electrosurgical procedures. The non-conductive, specialized plastic stops dangerous grounding of the electrical current that a metal would not. The stainless steel metal parts will not rust and are away from the operating area. The three main parts are injection molded from a plastic called ULTEM, a General Electric Company product used for many years in the manufacturing of medical devices, where high temperature and chemical interaction is a concern. The speculum has been autoclaved and cold soak sterilized for many hours to be sure of its usability after repeated cycles and there is no coating to breakdown, crack, chip, or peel. The color is pink to stop light reflection (as opposed to white) and still light enough to show any surface damage that might happen in use. The surfaces are polished and all sharp edges are removed for the protection of the patient.
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K Number
K991669Device Name
PMS 750 FINGERSWITCH
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
1999-08-12
(90 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMS750 Fingerswitch is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided non-sterile and is intended for limited reuse.
The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during electrosurgical procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.
Device Description
The PMS750 Fingerswitch Pencil is a non-sterile, limited reusable electrosurgical handcontrol pencil. It utilizes an insert-molded body that houses a printed circuit board; depression of the yellow button will activate the CUT circuit and depression of the blue button will activate the COAG circuit. It is an accessory to an ESU (electrosurgical unit or generator).
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K Number
K983840Device Name
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
1999-05-20
(202 days)
Product Code
HGI
Regulation Number
884.4120Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for in-office high frequency, electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include:
1) Cervical Conization.
2) Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
3) External Anogenital Lesions.
4) Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.
5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field, wet or dry.
Device Description
Not Found
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K Number
K984306Device Name
`THE INSEMINATOR' (PROPOSED)
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
1999-03-01
(89 days)
Product Code
MFD
Regulation Number
884.5250Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen. The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.
Device Description
The malleable catheter of Wallach's 'Inseminator' includes the fine, smoothed tip, with a flared proximal end. Insemination fluid (washed sperm) is introduced into the uterine cavity using a syringe attached to the proximal luer.
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K Number
K983208Device Name
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
1999-02-22
(161 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurgical procedures. Some indications for applications include:
- 1) Cutting skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection.
- 2) Blended Cutting and Coagulation skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures.
- 3) Hemostasis control of bleeding, epilation, and telangiectasia.
- 4) Fulguration basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis.
- 5) Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field; wet or dry.
Device Description
Not Found
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K Number
K963653Device Name
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
1997-06-11
(272 days)
Product Code
HGI
Regulation Number
884.4120Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Quantum 2000 System is for in-office electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include:
1) Cervical Conization.
2) Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
3) External Anogenital Lesions.
4) Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.
Device Description
WALLACH QUNATUM 2000 ELECTROSURGICAL SYSTEM
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K Number
K963348Device Name
WALLACH INTEGRATION UNIT
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
1997-03-19
(205 days)
Product Code
HGI
Regulation Number
884.4120Why did this record match?
Applicant Name (Manufacturer) :
WALLACH SURGICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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