Lubricating Jelly
FDA 510(k) clearance K142473 · decided 2015-04-13
Clearance details
- K-number
- K142473
- Device name
- Lubricating Jelly
- Applicant
- Sion Biotext Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-03
- Decision date
- 2015-04-13
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- KMJ
- Device class
- 1
- Regulation number
- 880.6375
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Upper Galilee, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COLONGLIDE LUBRICANT (K141028) | Pediatric Pharmaceuticals, Inc. | 2014-07-24 |
| COLONGLIDE(R) LUBRICANT (K131617) | Pediatric Pharmaceuticals, Inc. | 2013-10-03 |
| LUBE JELLY SURINGE (K121390) | Nurse Assist, Inc. | 2012-08-10 |
| DUKAL LUBRICATING JELLY (K113689) | Dukal Corporation | 2012-05-04 |
| STERILE LUBRICATING JELLY (K112110) | Jianerkang Medical Dressing Company | 2012-04-10 |
| DYNACOR LUBRICATION GEL (K103718) | Medline Industries, Inc. | 2011-05-10 |
| ULTRA SEAL STERILE LUBRICATING JELLY (K101522) | Ultra Seal Corporation | 2010-12-23 |
| DYNAREX STERILE LUBRICATING JELLY (K092488) | Dynarex Corporation | 2009-12-18 |
| STERI-LUB LUBRICATION GEL (K083189) | Avail Medical Products, Inc. | 2008-11-21 |
| SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (K073684) | Sheffield Industries, Div. of Faria , Ltd. | 2008-05-22 |
| SPIRUS MEDICAL SURGICAL INSTRUMENT (K080042) | Spirus Medical, Inc. | 2008-04-03 |
| DUREX PLAY WARMER LUBRICANT (K042563) | Ssl Americas, Inc. | 2005-02-23 |
Recalls involving this device
No recalls on record reference this clearance.