FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PUNCH BIOPSY KIT
K Number: K862562
·
Decision Oct 7, 1986
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
16
Review Days
96
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Basic Information
- Device Name
- PUNCH BIOPSY KIT
- K Number
- K862562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Clinipad Corp.
- Date Received
- July 3, 1986
- Decision Date
- October 7, 1986
- 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 Clinipad Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931560 | CARDIAC CATHETERIZATION TRAY | Jul 11, 1994 | Unknown |
| K931668 | PICC INSERTION TRAY | Mar 7, 1994 | Unknown |
| K932071 | I.V. START KIT | Feb 17, 1994 | Unknown |
| K932010 | V.A.D. ACCESS KIT | Feb 3, 1994 | Substantially Equivalent |
| K932036 | LACERATION TRAY | Dec 13, 1993 | Unknown |
| K932016 | TRACHEOSTOMY CARE TRAY | Nov 3, 1993 | Substantially Equivalent |
| K862563 | TRACHEOSTOMY CLEANSING SOLUTION | Jul 15, 1986 | Substantially Equivalent |
| K833075 | WET DRESSING KIT | Jan 27, 1984 | Substantially Equivalent |
| K833432 | CATHETER INSERTION KIT | Dec 28, 1983 | Substantially Equivalent |
| K830476 | OR PREP KIT | Mar 31, 1983 | Substantially Equivalent |