FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRO-CUT BIOPSY NEEDLE
K Number: K891777
·
Decision May 4, 1989
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
18
Review Days
41
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Basic Information
- Device Name
- PRO-CUT BIOPSY NEEDLE
- K Number
- K891777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Teknar, Inc.
- Date Received
- March 24, 1989
- Decision Date
- May 4, 1989
- Product Code
- FCG
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Teknar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903666 | OPHTHASONIC A/P III | Nov 19, 1990 | Substantially Equivalent |
| K896038 | B-SCAN 10 MHZ PROBE | Apr 23, 1990 | Substantially Equivalent |
| K896150 | IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC | Jan 18, 1990 | Substantially Equivalent |
| K883965 | PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR | Oct 5, 1988 | Substantially Equivalent |
| K881850 | TEKNAR PERCU-SCAN | Aug 29, 1988 | Substantially Equivalent |
| K881605 | BIOPSY GUIDE | Jun 21, 1988 | Substantially Equivalent |
| K880659 | TEKNAR PROSCAN ACCESSORY PROBE | Apr 14, 1988 | Substantially Equivalent |
| K871536 | OPHTHASONIC A-SCAN/ B-SCAN | Aug 26, 1987 | Substantially Equivalent for Some Indications |
| K864807 | TEKNAR PROSCAN(TM) | Jul 10, 1987 | Substantially Equivalent |
| K860757 | OPHTHASONIC A-SCAN | Dec 18, 1986 | Substantially Equivalent |