FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
K Number: K130282
·
Decision May 13, 2013
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
353
Applicant Total
14
Review Days
97
Basic Information
- Device Name
- REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
- K Number
- K130282
- 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
- February 5, 2013
- Decision Date
- May 13, 2013
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
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 | ||
|---|---|---|---|
| K150266 | Remington Medical Inc. Tuohy Epidural Needles | Jun 4, 2015 | 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 |
| K982401 | PROSTATE BIOPSY NEEDLE | Sep 8, 1998 | Substantially Equivalent |
| K972134 | BAG DECANTER | Aug 26, 1997 | Substantially Equivalent |
| K971968 | SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) | Jul 23, 1997 | Substantially Equivalent |
| K953812 | GAUZE SPONGE | Oct 2, 1995 | Substantially Equivalent |
| K946060 | REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8 | Apr 27, 1995 | Substantially Equivalent |