OPERAND LUBRICATING JELLY
FDA 510(k) clearance K912132 · decided 1991-08-07
Clearance details
- K-number
- K912132
- Device name
- OPERAND LUBRICATING JELLY
- Applicant
- General Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-14
- Decision date
- 1991-08-07
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- FHX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Prichard, WV, US
- 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 |
|---|---|---|
| LUBRICANO STERILE GEL (K081990) | Farco Pharma GmbH | 2008-12-05 |
| BUTTON LUBRICATOR (K951713) | Fibertech Instruments, Inc. | 1995-04-25 |
| CATHEJELL S STERILE LUBRICATING JELLY (K935548) | Pharmazeutische Fabrik Montavit GmbH | 1994-03-30 |
| K-Y LUBRICATING JELLY (K780386) | Johnson & Johnson Professionals, Inc. | 1978-04-13 |
| LUBE JEL (K771364) | Travenol Laboratories, S.A. | 1977-08-02 |
Recalls involving this device
No recalls on record reference this clearance.