FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CARAPACE WOUND DRESSING KITS & LACERATION TRAYS
K Number: K931758
·
Decision Jan 26, 1994
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
22
Review Days
293
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARAPACE WOUND DRESSING KITS & LACERATION TRAYS
- K Number
- K931758
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Carapace, Inc.
- Date Received
- April 8, 1993
- Decision Date
- January 26, 1994
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRO), ordered by most recent decision date.
Medline General Surgery Tray
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Cardiovascular Procedure Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGICAL DRAPE KIT - D.I.R.R.A. SRL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMSINO TRACHEOSTOMY CARE TRAY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K931670 | CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS | Jan 25, 1994 | Substantially Equivalent |
| K931759 | CARAPACE STERILE GAUZE TRAYS | Jan 25, 1994 | Unknown |