SUCTION IRRIGATOR
FDA 510(k) clearance K003443 · decided 2001-02-01
Clearance details
- K-number
- K003443
- Device name
- SUCTION IRRIGATOR
- Applicant
- Applied Medical
- Decision
- Substantially Equivalent
- Date received
- 2000-11-06
- Decision date
- 2001-02-01
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- FHF
- Device class
- 2
- Regulation number
- 876.4370
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rancho Santa, CA, 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 |
|---|---|---|
| DISPOSABLE SUCTION AND IRRIGATION SYSTEM (K093479) | Modern Medical Equipment Mfg., Ltd. | 2010-05-19 |
| CATHETER, MEDIASTINAL&PERICARDIAL (K771986) | The Minnesota Back Brace Co. | 1977-10-28 |
Recalls involving this device
No recalls on record reference this clearance.