Steri-Swab
FDA 510(k) K912731 · Westlock Investments (Usa), Inc.
510(k) numberK912731
Submission
- Device name
- Steri-Swab
- Applicant
- Westlock Investments (Usa), Inc.
Bellevue, WA, US - Received
- June 20, 1991
- Decision date
- October 2, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKB – Pad, Alcohol, Device Disinfectant
- Device class
- Unclassified
Other 510(k)s with product code LKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132380 | Prevantics Device SwabLKB · Traditional | Professional Disposables International, Inc. | 08/27/2014SE |
| K121655 | BD Alcohol SwabLKB · Traditional | Becton, Dickinson & CO | 03/20/2013SE |
| K112791 | Sitescrub Ipa DeviceLKB · Traditional | C. R. Bard | 02/24/2012SE |
| K912161 | I.V. Starr KitLKB · Traditional | Medical Device Inspection Co., Inc. | 10/08/1991SE |
| K910735 | Hexidis Alcohol SwabLKB · Traditional | Specialites Septodont | 04/02/1991SE |
| K896898 | Bowen Electrode Skin Prepatory CleanserLKB · Traditional | Bowen & Company, Inc. | 04/04/1990SE |
| K896835 | Alcohol Prep and Povidone-Iodine PrepLKB · Traditional | Norpak Mfg., Inc. | 01/11/1990SE |
| K894791 | Baxter Acetone-Alcohol Swabstick, SterileLKB · Traditional | Span-America Medical Systems, Inc. | 10/03/1989SE |
| K893958 | Baxter Acetone-Alcohol Prep Pads, SterileLKB · Traditional | Span-America Medical Systems, Inc. | 10/03/1989SE |
| K892193 | Quickpad (Alcohol Swabs)LKB · Traditional | Holtsch Co., Inc. | 08/04/1989SE |
Questions and answers
When was Steri-Swab cleared by the FDA?
Steri-Swab (K912731) received a 510(k) decision of Substantially Equivalent on October 2, 1991, 104 days after the submission was received.
What is the product code of K912731?
The FDA product code is LKB – Pad, Alcohol, Device Disinfectant, a Unclassified device.