Olympus Automatic Surgical Irrigation Pump
FDA 510(k) K953290 · Olympus America, Inc.
510(k) numberK953290
Submission
- Device name
- Olympus Automatic Surgical Irrigation Pump
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- July 14, 1995
- Decision date
- October 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KZD – Infusor, Pressure, For I.V. Bags
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5420
- Specialty
- General Hospital
Other 510(k)s with product code KZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974074 | Infusion Dynamics Power InfuserKZD · Traditional | Infusion Dynamics, Inc. | 02/17/1998SE |
| K973843 | Msi Pressure InfusorKZD · Traditional | Smith Assoc. | 10/29/1997SE |
| K951988 | PressurizerKZD · Traditional | Promedic, Inc. | 06/14/1995SE |
| K942933 | Pressure Infusion CuffKZD · Traditional | Circulatory Technology, Inc. | 08/25/1994SE |
| K930012 | Kawasumi Laboratories K-CuffKZD · Traditional | Kawasumi Laboratories Co., Ltd. | 12/14/1993SE |
| K921168 | Allen Infusion Pump Model 3000 and Irrigation 2000KZD · Traditional | Allen Medical Systems, Inc. | 04/21/1993SE |
| K913751 | Pressure InfuserKZD · Traditional | Biomedical Dynamics, Inc. | 01/09/1992SE |
| K910926 | Tecnadyne Surgi-Squeeze Infusion PumpKZD · Traditional | Tecnadyne Scientific, Inc. | 08/02/1991SE |
| K911216 | InfusableKZD · Traditional | Biomedical Dynamics, Inc. | 07/22/1991SE |
| K904484 | Baxter Single Patient Use Pressure InfusorKZD · Traditional | Tecnadyne Scientific, Inc. | 10/26/1990SE |
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Questions and answers
When was Olympus Automatic Surgical Irrigation Pump cleared by the FDA?
Olympus Automatic Surgical Irrigation Pump (K953290) received a 510(k) decision of Substantially Equivalent on October 7, 1995, 85 days after the submission was received.
What is the product code of K953290?
The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.