MANAN D BAG
FDA 510(k) clearance K961986 · decided 1997-03-13
Clearance details
- K-number
- K961986
- Device name
- MANAN D BAG
- Applicant
- Manan Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-21
- Decision date
- 1997-03-13
- Days to decision
- 296 days
- Clearance type
- Traditional
- Product code
- EXF
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Manan Medical Products
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 |
|---|---|---|
| MERIT DRAINAGE DEPOT (K003078) | Merit Medical Systems, Inc. | 2000-12-11 |
| DRAINAGE BAG (K990428) | Remington Medical, Inc. | 1999-08-12 |
| MANAN D BAG (K980005) | Medical Device Technologies, Inc. | 1998-01-30 |
| MANAN D BAG (K963849) | Manan Medical Products, Inc. | 1996-12-13 |
| NAVARRE 600 ML DRAINAGE BAG (K943663) | Navarre Biomedical , Ltd. | 1994-09-08 |
| MMG BILE BAG (K911129) | Medical Technologies of Georgia | 1991-08-07 |
| URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET (K903449) | Uresil Corp. | 1990-09-12 |
| URESIL TRU-CLOSE DRAINAGE BAG (K901844) | Uresil Corp. | 1990-06-01 |
Recalls involving this device
No recalls on record reference this clearance.