← Product Code [KZD](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD) · K953290

# OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP (K953290)

_Olympus America, Inc. · KZD · Oct 7, 1995 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD/K953290

## Device Facts

- **Applicant:** Olympus America, Inc.
- **Product Code:** [KZD](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD.md)
- **Decision Date:** Oct 7, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5420
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD/K953290](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD/K953290)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com