FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
K Number: K980211
·
Decision Feb 6, 1998
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
39
Review Days
16
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Basic Information
- Device Name
- MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
- K Number
- K980211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Manan Medical Products, Inc.
- Date Received
- January 21, 1998
- Decision Date
- February 6, 1998
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 Manan Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052802 | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE | Nov 1, 2005 | Substantially Equivalent |
| K011209 | MANAN SPRITACRE SPINAL NEEDLES | Jun 26, 2001 | Substantially Equivalent |
| K983620 | MANAN SPINAL NEEDLES | Jan 8, 1999 | Substantially Equivalent |
| K980536 | EPIDURAL NEEDLE | Jul 31, 1998 | Substantially Equivalent |
| K981386 | MANAN BLUNT NEEDLE | Jun 29, 1998 | Substantially Equivalent |
| K974446 | MANAN AUTOMATIC CUTTING NEEDLE | Jan 8, 1998 | Substantially Equivalent |
| K962977 | MRI COMPATIBLE BIOPSY NEEDLES | Oct 9, 1997 | Substantially Equivalent |
| K963767 | MANAN V.S. ACCESS NEEDLE/SET | May 16, 1997 | Substantially Equivalent |
| K961986 | MANAN D BAG | Mar 13, 1997 | Substantially Equivalent |
| K962001 | MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE | Jan 10, 1997 | Substantially Equivalent |