Sana-Lube
FDA 510(k) K853653 · Huntington Laboratories, Inc.
510(k) numberK853653
Submission
- Device name
- Sana-Lube
- Applicant
- Huntington Laboratories, Inc.
Huntington, IN, US - Received
- September 3, 1985
- Decision date
- November 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K083189 | Steri-Lub Lubrication GelKMJ · Special | Avail Medical Products, Inc. | 11/21/2008SE |
More from Avail Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960583 | Matar General Purpose DisinfectantLRJ · Traditional | 03/12/1996SE |
| K960582 | Ascend General Purpose DisinfectantLRJ · Traditional | 03/12/1996SE |
| K960580 | Beaucoup General Purpose DisinfectantLRJ · Traditional | 03/12/1996SE |
| K953011 | Formulation HWS-64 Epa Reg. No. 47371-131LRJ · Traditional | 08/11/1995SE |
| K953010 | Formulation HWS-256 Epa Reg. No. 47371-129LRJ · Traditional | 08/11/1995SE |
| K953009 | Formulation HWS-128 Epa Reg. No. 47371-130LRJ · Traditional | 08/11/1995SE |
Questions and answers
When was Sana-Lube cleared by the FDA?
Sana-Lube (K853653) received a 510(k) decision of Substantially Equivalent on November 13, 1985, 71 days after the submission was received.
What is the product code of K853653?
The FDA product code is KMJ – Lubricant, Patient, a Class I (low risk) device regulated under 21 CFR 880.6375.