Carapace Suture Removal Trays
FDA 510(k) K931819 · Carapace, Inc.
510(k) numberK931819
Submission
- Device name
- Carapace Suture Removal Trays
- Applicant
- Carapace, Inc.
Broken Arrow, OK, US - Received
- April 8, 1993
- Decision date
- January 26, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IRO – Vibrator, Therapeutic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5975
- Specialty
- Physical Medicine
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| K950441 | Conair Family Fitness Body EnergyIRO · Traditional | Conair Corp. | 07/18/1995SE |
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| K950410 | Conair Body and SoleIRO · Traditional | Conair Corp. | 05/23/1995SE |
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More from Ultrassage, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931722 | Carapace Labor and Delivery SetsMLS · Traditional | 03/23/1994SEKD |
| K931822 | Carapace Pelvic Exam TraysMLT · Traditional | 03/07/1994SESK |
| 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 |
| 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 Suture Removal Trays cleared by the FDA?
Carapace Suture Removal Trays (K931819) received a 510(k) decision of Unknown on January 26, 1994, 293 days after the submission was received.
What is the product code of K931819?
The FDA product code is IRO – Vibrator, Therapeutic, a Class I (low risk) device regulated under 21 CFR 890.5975.