MILL-ROSE SCOPE CLEANING BRUSH
FDA 510(k) clearance K946293 · decided 1995-02-16
Clearance details
- K-number
- K946293
- Device name
- MILL-ROSE SCOPE CLEANING BRUSH
- Applicant
- Mill-Rose Laboratory
- Decision
- Substantially Equivalent
- Date received
- 1994-12-27
- Decision date
- 1995-02-16
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- MNL
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mill-Rose Laboratory
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 |
|---|---|---|
| UCB (K950689) | Cox Medical Ent., Inc. | 1995-03-06 |
| ENDO-SPONGE (K892218) | Endovations | 1989-05-31 |
| CLEANING BRUSH (K874239) | Endovations | 1987-12-29 |
Recalls involving this device
No recalls on record reference this clearance.