MICROFLOW IRRIGATION SYSTEM
FDA 510(k) clearance K941356 · decided 1994-05-19
Clearance details
- K-number
- K941356
- Device name
- MICROFLOW IRRIGATION SYSTEM
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-21
- Decision date
- 1994-05-19
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- GBQ
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Louis, MO, 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 |
|---|---|---|
| CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT (K921464) | Trinity Laboratories, Inc. | 1992-05-05 |
| GESCO CATHETERIZATION TRAY (K882647) | Gesco Intl., Inc. | 1988-09-09 |
| PERFORATED SOAKING TUBE (K874596) | Specialty Medical Products Co. | 1987-12-02 |
| PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (K873097) | Ipax, Inc. | 1987-09-04 |
| MODIFIED CURLCATH (K872787) | Quinton, Inc. | 1987-08-04 |
| GASTRIC LAVAGE KIT-DISPOSABLE (K791400) | Acumed Instruments Corp. | 1979-08-16 |
| THORNTON ANTERIOR CHAMBER IRRIGATOR (K771732) | Concept, Inc. | 1977-09-28 |
Recalls involving this device
No recalls on record reference this clearance.