Identity
- Trade Name
- QCA-16-6.0-25T FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Model / Reference
- G61606 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212025204 FDA UDI
- 510(k) Number
- K973565 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Soft-tissue biopsy procedure kit, non-medicated 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
No
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
No
FDA UDI
Category: Soft-tissue biopsy procedure kit, non-medicated
Qca-16-6.0-25t by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue biopsy procedure kit, non-medicated.
- TEMNO® — Merit Medical Systems, Inc. · Class II
- MEDONE — Medax Unipersonale Srl · Class II
- MAMMOREP LOOP MLX — STERYLAB SRL · Class II
- MEDCUT — Medax Unipersonale Srl · Class II
- TEMNO® — Merit Medical Systems, Inc. · Class II
- CorVocet™ — Merit Medical Systems, Inc. · Class II
- CorVocet™ — Merit Medical Systems, Inc. · Class II
- MEDONE ULTRA — Medax Unipersonale Srl · Class II
Cleared under the same submission
K973565 also covers:
- DualCore Biopsy System w/Coax-12g x 10cm — IZI MEDICAL PRODUCTS LLC
- DualCore Biopsy System w/Coax-12g x 10cm 5pk — IZI MEDICAL PRODUCTS LLC
- DualCore Biopsy System w/Coax-12g x 16cm 5pk — IZI MEDICAL PRODUCTS LLC
- DualCore Biopsy System w/Coax-14g x 16cm 5pk — IZI MEDICAL PRODUCTS LLC
- DualCore Biopsy System-12g x 10cm — IZI MEDICAL PRODUCTS LLC
- DualCore Biopsy System-16g x 10cm — IZI MEDICAL PRODUCTS LLC
- DualCore Biopsy System-16g x 10cm 5pk — IZI MEDICAL PRODUCTS LLC
- DualCore Biopsy System-16g x 16cm 5pk — IZI MEDICAL PRODUCTS LLC
- QC Auto 12G 12CM 25T 5PK — IZI MEDICAL PRODUCTS LLC
- QC Auto 16G 12CM 25T 5PK — IZI MEDICAL PRODUCTS LLC
- QC Auto 16G 16CM 25T 5PK — IZI MEDICAL PRODUCTS LLC
- QC Auto 18G 12CM 25T 5PK — IZI MEDICAL PRODUCTS LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Izi Medical Products Llc
Sources (1)
- FDA UDI 2a4aafe7-cc1b-4528-b70b-e78c15fbaee5 33 fields · synced May 30, 2026