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510(k) Data Aggregation
K Number
K172661Device Name
Fetzer Medical Gynecological Forceps
Manufacturer
Fetzer Medical GmbH & Co. KG
Date Cleared
2018-05-08
(245 days)
Product Code
HCZ
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
**Fetzer Medical GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fetzer Medical Gynecological Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.
Device Description
This 510(k) covers 31 devices a total of 132 variants representing three general designs (vulsellum, tenaculum, and hysterectomy). These products are reusable manual surgical instruments to be used in gynecological procedures. They are scissor-like, self-retaining devices with ring handles and two blades and made of high-grade stainless steel or titanium. They are available in various sizes with different blade designs at the distal end (e.g., straight or curved). Some of these devices have an additional grasping claw at the distal end. The blades are heavily serrated or may have a profiled longitudinal groove to provide extra grip of the organ.
The subject devices vary in the jaw configurations and curvature to meet the surgeon's needs and preferences, based on individual, anatomical variations of the patients. The products are sold nonsterile and can be reused (cleaned and sterilized) according to the instructions for use.
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K Number
K163524Device Name
Vessel Dilator
Manufacturer
Fetzer Medical GmbH & Co. KG
Date Cleared
2017-06-29
(196 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
Applicant Name (Manufacturer) :
**Fetzer Medical GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.
Device Description
Fetzer Medical Vessel Dilators are reusable manual surgical instruments. They are rod-like devices with a long, slender, solid shaft and a distal tip of various shapes and sizes. They are sold unsterile and can be reused (cleaned and sterilized) according the instructions for use.
There are several types of dilators made from stainless steel or aluminum:
- Cooley Coronary Dilators
- Cooley Vessel Dilators
- Garrett Vascular Dilators
- Hiebert Vascular Dilators
- DeBakey Vascular Dilators
- Sarns-Style Dilators
- Myocardial Dilators
These dilators are available in a range of different length and diameters.
The handle of the DeBakey Vascular Dilator, the Cooley Vessel Dilator, the Cooley Coronary Dilator, the Hiebert Vascular Dilator and the Garrett Vascular Dilator is textured with one site flat. The handles of the Sarns and Myocardial Dilators are smooth. The Myocardial Dilator has a flat distal end for holding it and the Sarns Dilator has a hollow handle at the distal end.
Apart from the Hiebert Vascular Dilator and the Myocardial Dilator, the handle is connected to a thin shaft. The diameter of the shaft of the different dilator types varies. The shaft of the Cooley Coronary Dilator, the Cooley Vessel Dilator, The Garrett Vascular Dilator and the DeBakey Vascular Dilator can be thin so that the shaft is flexible. The handle of the Myocardial Dilator has no shaft while the Hiebert Vascular Dilator is double-ended; it possesses two flexible shafts, with the handle located in between the two thin shafts.
The tips of all dilators have the aim to enlarge a vessel. The design of the Sarns and Myocardial Dilator is similar to an elephant's tusk. The diameter increases steadily, moving towards the handle's direction. The tips of the other Dilators are olive-shaped. The Cooley Coronary Dilator possesses no formed tip. For all dilators, the penetrating diameter corresponds to the diameter of the shaft. The Hiebert Vascular Dilators working elements are each malleable wires with an olive tip in different diameters.
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K Number
K161004Device Name
Self-retaining Retractor
Manufacturer
FETZER MEDICAL GMBH & CO.KG
Date Cleared
2016-09-09
(151 days)
Product Code
GZT
Regulation Number
882.4800Why did this record match?
Applicant Name (Manufacturer) :
**FETZER MEDICAL GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.
Device Description
Fetzer Medical Self-retaining Retractors are reusable manual instruments made from stainless steel, aluminum or titanium. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use. Devices are available with the following features: frame type retractors, Ring handle retractors, MIS Port retractor.
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