Sterile Design
FDA 510(k) K934688 · Sterile Design, Inc.
510(k) numberK934688
Submission
- Device name
- Sterile Design
- Applicant
- Sterile Design, Inc.
Oldsmar, FL, US - Received
- September 30, 1993
- Decision date
- March 16, 1994
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K841960 | Cardio Metrics Invasive Pressure MonitDRS · Traditional | 11/08/1985SE |
| K842356 | Custom Sterile Procedure Kits · Traditional | 03/21/1985SE |
| K841959 | Cardio Metric Custom Perfusion TubingDWE · Traditional | 10/19/1984SE |
| K842351 | Sterile Design-Custom Sterile IV KitFPA · Traditional | 10/15/1984SE |
| K841958 | Cardio Metrics Cardiotomy ReservoirJOD · Traditional | 10/15/1984SE |
| K834239 | Sdi C-Flex Sterile Light Handle · Traditional | 04/25/1984SE |
| K834237 | Graduated Guide Wire Bowl 8DQX · Traditional | 02/04/1984SE |
| K813437 | Pan SetFRG · Traditional | 12/31/1981SE |
| K791738 | Custom Dressing Change TraysFMC · Traditional | 10/02/1979SE |
Questions and answers
When was Sterile Design cleared by the FDA?
Sterile Design (K934688) received a 510(k) decision of Unknown on March 16, 1994, 167 days after the submission was received.
What is the product code of K934688?
The FDA product code is LRO – General Surgery Tray, a Class II (moderate risk) device regulated under 21 CFR 878.4370.