KY Grosz Jelly
FDA 510(k) clearance K201186 · decided 2020-07-30
Clearance details
- K-number
- K201186
- Device name
- KY Grosz Jelly
- Applicant
- Rb Health (Us), LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-05-01
- Decision date
- 2020-07-30
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Rb Health (Us)
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| KY JELLY LUBRICANT 2 FL OZ, SKU 901443 recall (Z-1547-2022) | Family Dollar Stores, Llc. | 2022-08-17 |