Microflow Irrigation System
FDA 510(k) K941356 · Jedmed Instrument Co.
510(k) numberK941356
Submission
- Device name
- Microflow Irrigation System
- Applicant
- Jedmed Instrument Co.
St. Louis, MO, US - Received
- March 21, 1994
- Decision date
- May 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBQ – Catheter, Continuous Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K874596 | Perforated Soaking TubeGBQ · Traditional | Specialty Medical Products Co. | 12/02/1987SE |
| K873097 | Procedual Changes/Assembly Process for Plus PaksGBQ · Traditional | Ipax, Inc. | 09/04/1987SE |
| K872787 | Modified CurlcathGBQ · Traditional | Quinton, Inc. | 08/04/1987SE |
| K791400 | Gastric Lavage Kit-DisposableGBQ · Traditional | Acumed Instruments Corp. | 08/16/1979SE |
| K771732 | Thornton Anterior Chamber IrrigatorGBQ · Traditional | Concept, Inc. | 09/28/1977SE |
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Questions and answers
When was Microflow Irrigation System cleared by the FDA?
Microflow Irrigation System (K941356) received a 510(k) decision of Substantially Equivalent on May 19, 1994, 59 days after the submission was received.
What is the product code of K941356?
The FDA product code is GBQ – Catheter, Continuous Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.