Identity
- Trade Name
- Praxis Medical FDA UDI
- Generic Name
- Biopsy syringe holder, reusable FDA UDI
- Device Name
- The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor which rotates the needle clockwise and counterclockwise motion to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells. FDA UDI
- Model / Reference
- C0025 FDA UDI
- Description
- The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor which rotates the needle clockwise and counterclockwise motion to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003935804 FDA UDI
- 510(k) Number
- K200278 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Biopsy syringe holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biopsy syringe holder, reusable
Praxis Medical by Praxis Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200278 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Praxis Medical Llc
Sources (1)
- FDA UDI 63760b3f-0343-485f-a9fd-1445af7df8dd 34 fields · synced Jun 8, 2026