DISPOSABLE SUCTION AND IRRIGATION SYSTEM
FDA 510(k) clearance K093479 · decided 2010-05-19
Clearance details
- K-number
- K093479
- Device name
- DISPOSABLE SUCTION AND IRRIGATION SYSTEM
- Applicant
- Modern Medical Equipment Mfg., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-09
- Decision date
- 2010-05-19
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- FHF
- Device class
- 2
- Regulation number
- 876.4370
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Heng Li, Dongguan, Guangdong, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Modern Medical Equipment Mfg.
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 |
|---|---|---|
| SUCTION IRRIGATOR (K003443) | Applied Medical | 2001-02-01 |
| CATHETER, MEDIASTINAL&PERICARDIAL (K771986) | The Minnesota Back Brace Co. | 1977-10-28 |
Recalls involving this device
No recalls on record reference this clearance.