INJECTO FLUSH
Device Facts
| Record ID | K964120 |
|---|---|
| Device Name | INJECTO FLUSH |
| Applicant | Robert J. Jynch, Jr. |
| Product Code | FCL · Gastroenterology, Urology |
| Decision Date | Dec 30, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 1 |
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.
Indications for Use
Indicated for flushing reusable biopsy forceps and canulated instruments in clinical or institutional settings.
Regulatory Classification
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.
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- K964871 — BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS · Biosearch Medical Products, Inc. · Mar 3, 1997
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