← Product Code [FCL](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCL) · K964120

# INJECTO FLUSH (K964120)

_Robert J. Jynch, Jr. · FCL · Dec 30, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCL/K964120

## Device Facts

- **Applicant:** Robert J. Jynch, Jr.
- **Product Code:** [FCL](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCL.md)
- **Decision Date:** Dec 30, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1075
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Indications for Use

The Injecto Flush was designed to give a more practical and consistent way of flushing out reusable biopsy forceps and canulated instruments.

## Device Story

Disposable, recyclable flushing unit; designed for cleaning reusable biopsy forceps and canulated instruments; replaces expensive disposable instruments with reusable alternatives; minimizes cross-contamination risk; used in medical institutions/facilities; manual operation by clinical staff; provides consistent flushing mechanism; cost-containment benefit.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Disposable, recyclable flushing unit; manual operation; non-powered.

## Regulatory Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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510(k) k964120

DEC 30 1996

# SUMMARY

The Injecto Flush was designed to give a more practical and consistent way of flushing out reusable biopsy forceps and canulated instruments.

The Injecto Flush was also designed to have no effect on the break down of instrumentation nor any possibility of cross contamination. The Injecto Flush is a one time disposable, but totally recyclable flushing unit.

In this day and age when cost containment plays a big factor in the medical profession, the Injecto Flush also offers the opportunity for institutions and health facilities to do away with one time expensive disposable instruments and revert to a reusable instrument but, inexpensive flushing device with no additional risks of any kind.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCL/K964120](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCL/K964120)

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