Steri-Lub Lubrication Gel
FDA 510(k) K083189 · Avail Medical Products, Inc.
510(k) numberK083189
Submission
- Device name
- Steri-Lub Lubrication Gel
- Applicant
- Avail Medical Products, Inc.
Santa Ana, CA, US - Received
- October 29, 2008
- Decision date
- November 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMJ – Lubricant, Patient
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6375
- Specialty
- General Hospital
Other 510(k)s with product code KMJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142473 | Lubricating JellyKMJ · Traditional | Sion Biotext Medical , Ltd. | 04/13/2015SE |
| K141028 | Colonglide LubricantKMJ · Special | Pediatric Pharmaceuticals, Inc. | 07/24/2014SE |
| K131617 | Colonglide(R) LubricantKMJ · Traditional | Pediatric Pharmaceuticals, Inc. | 10/03/2013SE |
| K121390 | Lube Jelly SuringeKMJ · Traditional | Nurse Assist, Inc. | 08/10/2012SE |
| K113689 | Dukal Lubricating JellyKMJ · Traditional | Dukal Corporation | 05/04/2012SE |
| K112110 | Sterile Lubricating JellyKMJ · Traditional | Jianerkang Medical Dressing Company | 04/10/2012SE |
| K103718 | Dynacor Lubrication GelKMJ · Traditional | Medline Industries, Inc. | 05/10/2011SE |
| K101522 | Ultra Seal Sterile Lubricating JellyKMJ · Traditional | Ultra Seal Corporation | 12/23/2010SE |
| K092488 | Dynarex Sterile Lubricating JellyKMJ · Traditional | Dynarex Corporation | 12/18/2009SE |
| K073684 | Sheffield Pharmaceuticals (Sterile) LubrigelKMJ · Traditional | Sheffield Industries, Div. of Faria , Ltd. | 05/22/2008SE |
More from Sheffield Industries, Div. of Faria , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K112209 | Prefilled Catheter Inflation SyringeKNY · Special | 09/08/2011SE |
| K090121 | Pre-Filled Catheter Inflation SyringeKNY · Special | 04/15/2009SE |
| K030149 | Medtronic Minimed Sof-Site Infusion Set, Models MMT-359S6, MMT-359M6, MMT-359L6…FPA · Traditional | 03/20/2003SE |
| K030137 | Medtronic Minimed Sof-Site Infusion Set, Models MMT-358S6, MMT-358M6, MMT-358L6…FPA · Traditional | 02/19/2003SE |
Questions and answers
When was Steri-Lub Lubrication Gel cleared by the FDA?
Steri-Lub Lubrication Gel (K083189) received a 510(k) decision of Substantially Equivalent on November 21, 2008, 23 days after the submission was received.
What is the product code of K083189?
The FDA product code is KMJ – Lubricant, Patient, a Class I (low risk) device regulated under 21 CFR 880.6375.