TRAY, BLADDER IRRIGATION
FDA 510(k) clearance K760047 · decided 1977-03-01
Clearance details
- K-number
- K760047
- Device name
- TRAY, BLADDER IRRIGATION
- Applicant
- M-C Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-06-15
- Decision date
- 1977-03-01
- Days to decision
- 259 days
- Clearance type
- Traditional
- Product code
- EYN
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch M-C Ind.
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 |
|---|---|---|
| IRRIGATION TRAY (K944882) | Clinical Resources, Inc. | 1995-01-12 |
| IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (K923941) | American Healthcare Corp. | 1993-06-17 |
| IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (K923939) | American Healthcare Corp. | 1993-06-17 |
| IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (K923938) | American Healthcare Corp. | 1993-06-17 |
| IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (K923940) | American Healthcare Corp. | 1993-06-17 |
| KIT PAK IRRIGATION TRAY (K900148) | Kit Pak, Inc. | 1990-04-23 |
| PISTON IRRIGATION TRAY (K900737) | Orion Life Systems, Inc. | 1990-04-19 |
| BULB IRRIGATION TRAY (K900736) | Orion Life Systems, Inc. | 1990-04-17 |
| CATHETER IRRIGATION TRAYS, #3300, 3310 & (K801783) | The Healthcare Group Laboratories, Inc. | 1980-08-13 |
| GAVAGE FEEDING SET (K792082) | Medical Devices, Inc. | 1979-11-13 |
| FLUID ADMINISTRATION SET FA-3160 (K791020) | Burron Medical Products, Inc. | 1979-06-27 |
| GREENLINE IRRIGATION TRAYS (K790607) | Snyder Laboratories, Inc. | 1979-05-11 |
Recalls involving this device
No recalls on record reference this clearance.