FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
K Number: K932653
·
Decision Jan 28, 1994
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
22
Review Days
240
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Basic Information
- Device Name
- SWISSTEK 2000(TM) CAST REMOVAL SYSTEM
- K Number
- K932653
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5960
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Carapace, Inc.
- Date Received
- June 2, 1993
- Decision Date
- January 28, 1994
- Product Code
- LGH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LGH | Instrument, Cast Removal, Ac-Powered | FDA class 1 | Orthopedic |
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Other Clearances by Carapace, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931722 | CARAPACE LABOR AND DELIVERY SETS | Mar 23, 1994 | Unknown |
| K931822 | CARAPACE PELVIC EXAM TRAYS | Mar 7, 1994 | Unknown |
| K931729 | I.V. START KIT | Feb 22, 1994 | Unknown |
| K931820 | CARAPACE STILLWATER BOWL SET | Feb 7, 1994 | Unknown |
| K931669 | CARAPACE DEBRIDEMENT KITS | Feb 7, 1994 | Unknown |
| K931760 | CARAPACE PACKING GAUZE TRAYS | Feb 4, 1994 | Unknown |
| K931758 | CARAPACE WOUND DRESSING KITS & LACERATION TRAYS | Jan 26, 1994 | Unknown |
| K931819 | CARAPACE SUTURE REMOVAL TRAYS | Jan 26, 1994 | Unknown |
| K931670 | CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS | Jan 25, 1994 | Substantially Equivalent |
| K931759 | CARAPACE STERILE GAUZE TRAYS | Jan 25, 1994 | Unknown |