FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Remington Medical, Inc. Automatic Cutting Needle (NAC)
K Number: K191315
·
Decision Jul 12, 2019
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
19
Review Days
58
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Basic Information
- Device Name
- Remington Medical, Inc. Automatic Cutting Needle (NAC)
- K Number
- K191315
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remington Medical, Inc.
- Date Received
- May 15, 2019
- Decision Date
- July 12, 2019
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Remington Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) | Nov 20, 2025 | Substantially Equivalent |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) | Aug 30, 2024 | Substantially Equivalent |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | Jan 27, 2022 | Substantially Equivalent |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Oct 7, 2021 | Substantially Equivalent |
| K150266 | Remington Medical Inc. Tuohy Epidural Needles | Jun 4, 2015 | Substantially Equivalent |
| K130282 | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT | May 13, 2013 | Substantially Equivalent |
| K050884 | ADAPTER CABLE | May 19, 2005 | Substantially Equivalent |
| K040266 | CORE NEEDLE BIOPSY | Jul 9, 2004 | Substantially Equivalent |
| K990428 | DRAINAGE BAG | Aug 12, 1999 | Substantially Equivalent |
| K983621 | NEEDLE GUIDE | Nov 3, 1998 | Substantially Equivalent |