Carapace Pelvic Exam Trays
FDA 510(k) K931822 · Carapace, Inc.
510(k) numberK931822
Submission
- Device name
- Carapace Pelvic Exam Trays
- Applicant
- Carapace, Inc.
Broken Arrow, OK, US - Received
- April 8, 1993
- Decision date
- March 7, 1994
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MLT – Pelvic Exam Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
More from Carapace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931722 | Carapace Labor and Delivery SetsMLS · Traditional | 03/23/1994SEKD |
| K931729 | I.V. Start KitFOZ · Traditional | 02/22/1994SEKD |
| K931820 | Carapace Stillwater Bowl SetLRO · Traditional | 02/07/1994SESK |
| K931669 | Carapace Debridement KitsFRG · Traditional | 02/07/1994SESK |
| K931760 | Carapace Packing Gauze TraysLRO · Traditional | 02/04/1994SESK |
| K932653 | Swisstek 2000(TM) Cast Removal SystemLGH · Traditional | 01/28/1994SE |
| K931819 | Carapace Suture Removal TraysIRO · Traditional | 01/26/1994SEKD |
| K931758 | Carapace Wound Dressing Kits & Laceration TraysLRO · Traditional | 01/26/1994SEKD |
| K931759 | Carapace Sterile Gauze TraysLRO · Traditional | 01/25/1994SESK |
| K931670 | Carapace Epidural Block & Spinal Myelogram TraysCAZ · Traditional | 01/25/1994SE |
Questions and answers
When was Carapace Pelvic Exam Trays cleared by the FDA?
Carapace Pelvic Exam Trays (K931822) received a 510(k) decision of Unknown on March 7, 1994, 333 days after the submission was received.
What is the product code of K931822?
The FDA product code is MLT – Pelvic Exam Kit, a Class II (moderate risk) device regulated under 21 CFR 884.4530.