TOMAC LUBRICATING JELLY
FDA 510(k) clearance K822143 · decided 1982-07-30
Clearance details
- K-number
- K822143
- Device name
- TOMAC LUBRICATING JELLY
- Applicant
- American Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-21
- Decision date
- 1982-07-30
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- KMJ
- Device class
- 1
- Regulation number
- 880.6375
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch American Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Lubricating Jelly (K142473) | Sion Biotext Medical , Ltd. | 2015-04-13 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S002) | American Medical Systems, Inc. | 1998-12-23 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S001) | American Medical Systems, Inc. | 1998-01-09 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012) | American Medical Systems, Inc. | 1995-12-27 |