FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
CARAPACE INCISION AND DRAINAGE TRAYS
K Number: K931597
·
Decision Nov 5, 1993
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
14
Applicant Total
22
Review Days
218
Basic Information
- Device Name
- CARAPACE INCISION AND DRAINAGE TRAYS
- K Number
- K931597
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- CARAPACE, INC.
- Date Received
- April 1, 1993
- Decision Date
- November 5, 1993
- Product Code
- MCZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MCZ | Suture Removal Kit | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCZ), ordered by most recent decision date.
AMSINO SUTURE REMOVAL KIT
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PROD. NO. 01-132 - SUTURE REMOVAL KIT
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SUTURE REMOVAL KIT
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STERILE SUTURE REMOVAL KIT
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FDA Class 1
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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 |
| K932653 | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | Jan 28, 1994 | Substantially Equivalent |
| K931819 | CARAPACE SUTURE REMOVAL TRAYS | Jan 26, 1994 | Unknown |
| K931758 | CARAPACE WOUND DRESSING KITS & LACERATION TRAYS | Jan 26, 1994 | Unknown |
| K931759 | CARAPACE STERILE GAUZE TRAYS | Jan 25, 1994 | Unknown |