IRRIGATION CATHETER
FDA 510(k) clearance K760556 · decided 1977-02-17
Clearance details
- K-number
- K760556
- Device name
- IRRIGATION CATHETER
- Applicant
- Sherwood Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1976-09-01
- Decision date
- 1977-02-17
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- KDH
- 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
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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 |
|---|---|---|
| GILTECH PLUS CONNECTING TUBE SET (K983624) | Giltech Plus, Inc. | 1999-03-18 |
| SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS (K981286) | Armm, Inc. | 1998-06-19 |
| COMBIPORT FLUID LAVAGE DEVICE (K971259) | B.Braun Medical, Inc. | 1997-10-27 |
| TUM-E-VAC (K962850) | Ethox Corp. | 1997-02-21 |
| EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (K951533) | Ballard Medical Products | 1995-07-05 |
| FLUSHING IRRIGATION SET (K923497) | Orion Life Systems, Inc. | 1994-03-21 |
| TRI-MED GASTRIC LAVAGE SYSTEM (K920619) | Tri-Med Specialties, Inc. | 1992-09-04 |
| TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (K920527) | Tri-Med Specialties, Inc. | 1992-09-04 |
| QUICVAGE PLUS (K914908) | Autovage | 1992-04-13 |
| QUICVAGE (K914907) | Autovage | 1992-01-24 |
| ECONOVAGE R (K911788) | Autovage | 1991-07-26 |
| MINIVAGE(R) (K911919) | Autovage | 1991-07-26 |
Recalls involving this device
No recalls on record reference this clearance.