FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CARAPACE DEBRIDEMENT KITS
K Number: K931669
·
Decision Feb 7, 1994
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
22
Review Days
307
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Basic Information
- Device Name
- CARAPACE DEBRIDEMENT KITS
- K Number
- K931669
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Carapace, Inc.
- Date Received
- April 6, 1993
- Decision Date
- February 7, 1994
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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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 |
| K931760 | CARAPACE PACKING GAUZE TRAYS | Feb 4, 1994 | Unknown |
| K932653 | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | Jan 28, 1994 | Substantially Equivalent |
| 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 |