Medline General Surgery Tray
FDA 510(k) K213481 · Medline Industries, Inc.
510(k) numberK213481
Submission
- Device name
- Medline General Surgery Tray
- Applicant
- Medline Industries, Inc.
Northfiled, IL, US - Received
- October 29, 2021
- Decision date
- May 24, 2022
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|---|
| 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 |
| K970187 | Runyon Large Volume Paracentesis KitLRO · Traditional | Gi Supply | 02/14/1997SE |
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Questions and answers
When was Medline General Surgery Tray cleared by the FDA?
Medline General Surgery Tray (K213481) received a 510(k) decision of Substantially Equivalent on May 24, 2022, 207 days after the submission was received.
What is the product code of K213481?
The FDA product code is LRO – General Surgery Tray, a Class II (moderate risk) device regulated under 21 CFR 878.4370.