Carapace Instrumlent and Instrument Sets
FDA 510(k) K931824 · Carapace, Inc.
510(k) numberK931824
Submission
- Device name
- Carapace Instrumlent and Instrument Sets
- Applicant
- Carapace, Inc.
Broken Arrow, OK, US - Received
- April 8, 1993
- Decision date
- December 6, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRO – General Surgery Tray
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Other 510(k)s with product code LRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213481 | Medline General Surgery TrayLRO · Traditional | Medline Industries, Inc. | 05/24/2022SE |
| K212258 | Medline Cardiovascular Procedure KitLRO · Traditional | Medline Industries, Inc. | 12/03/2021SE |
| K041080 | Surgical Drape Kit - D.I.R.R.A. SRLLRO · Traditional | D.I.R.R.A. S.R.L. | 11/30/2004SE |
| K030721 | Quick-Tap Paracentesis Tray, Kit & NeedleLRO · Special | Ballard Medical Products | 03/31/2003SE |
| K023276 | Amsino Tracheostomy Care TrayLRO · Traditional | Amsino International, Inc. | 12/09/2002SE |
| K980137 | Worldwide Medical Technologies Bone Marrow Biopsy Procedure TrayLRO · Traditional | Worldwide Medical Technologies, LLC | 01/30/1998SE |
| K971061 | Opportunity Inc. Bone Marrow Biopsy and Aspiration TrayLRO · Traditional | Opportunity, Inc. | 06/11/1997SN |
| K971062 | Opportunity Inc. General Purpose TrayLRO · Traditional | Opportunity, Inc. | 06/09/1997SN |
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | Associated Medical Products Co. | 03/19/1997SE |
| K970286 | Presbyterian Linen Services Surgical PacksLRO · Traditional | Medline Industries, Inc. | 03/10/1997SE |
More from Medline Industries, 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 |
| 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 |
Questions and answers
When was Carapace Instrumlent and Instrument Sets cleared by the FDA?
Carapace Instrumlent and Instrument Sets (K931824) received a 510(k) decision of Unknown on December 6, 1993, 242 days after the submission was received.
What is the product code of K931824?
The FDA product code is LRO – General Surgery Tray, a Class II (moderate risk) device regulated under 21 CFR 878.4370.