FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACRI R NEEDLE
K Number: K980248
·
Decision Feb 18, 1998
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
10
Review Days
26
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Basic Information
- Device Name
- ACRI R NEEDLE
- K Number
- K980248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gallini U.S., LLC
- Date Received
- January 23, 1998
- Decision Date
- February 18, 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 Gallini U.S., LLC
| K Number | Device Name | ||
|---|---|---|---|
| K992499 | GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE | Aug 12, 1999 | Substantially Equivalent |
| K990645 | GALLINI ATRA-CUT NEEDLE | May 19, 1999 | Substantially Equivalent |
| K990716 | GALLINI BYCUT NEEDLE | May 17, 1999 | Substantially Equivalent |
| K981301 | SPEED-CUT AUTOMATIC BIOPSY SYSTEM | Jul 8, 1998 | Substantially Equivalent |
| K980676 | SPIGAL NEEDLE | May 21, 1998 | Substantially Equivalent |
| K980479 | QUICK-CUT AUTOMATIC BIOPSY SYSTEM | May 6, 1998 | Substantially Equivalent |
| K974440 | IBI | Jan 30, 1998 | Substantially Equivalent |
| K973152 | GALLINI ABS DEVICE | Jan 9, 1998 | Substantially Equivalent |
| K972266 | GALLINI COAXIAL INTRODUCER | Jul 29, 1997 | Substantially Equivalent |