Aquagel Lubricating Jelly
FDA 510(k) K951431 · Depuy Healthcare
510(k) numberK951431
Submission
- Device name
- Aquagel Lubricating Jelly
- Applicant
- Depuy Healthcare
Stow, MA, US - Received
- March 27, 1995
- Decision date
- July 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K083189 | Steri-Lub Lubrication GelKMJ · Special | Avail Medical Products, Inc. | 11/21/2008SE |
Questions and answers
When was Aquagel Lubricating Jelly cleared by the FDA?
Aquagel Lubricating Jelly (K951431) received a 510(k) decision of Substantially Equivalent on July 21, 1995, 116 days after the submission was received.
What is the product code of K951431?
The FDA product code is KMJ – Lubricant, Patient, a Class I (low risk) device regulated under 21 CFR 880.6375.