FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CARAPACE PELVIC EXAM TRAYS
K Number: K931822
·
Decision Mar 7, 1994
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
0
Applicant Total
22
Review Days
333
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 PELVIC EXAM TRAYS
- K Number
- K931822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Carapace, Inc.
- Date Received
- April 8, 1993
- Decision Date
- March 7, 1994
- Product Code
- MLT
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| MLT | Pelvic Exam Kit | FDA class 2 | Obstetrics/Gynecology |
Other Clearances by Carapace, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931722 | CARAPACE LABOR AND DELIVERY SETS | Mar 23, 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 |
| 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 |