GBQ · Catheter, Continuous Irrigation
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GBQ |
|---|---|
| Device Name | Catheter, Continuous Irrigation |
| Regulation | 21 CFR 878.4200 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K941356 | MICROFLOW IRRIGATION SYSTEM | Jedmed Instrument Co. | May 19, 1994 | SESE |
| K921464 | CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT | Trinity Laboratories, Inc. | May 5, 1992 | SESE |
| K882647 | GESCO CATHETERIZATION TRAY | Gesco Intl., Inc. | Sep 9, 1988 | SESD |
| K874596 | PERFORATED SOAKING TUBE | Specialty Medical Products Co. | Dec 2, 1987 | SESE |
| K873097 | PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS | Ipax, Inc. | Sep 4, 1987 | SESE |
| K872787 | MODIFIED CURLCATH | Quinton, Inc. | Aug 4, 1987 | SESE |
| K791400 | GASTRIC LAVAGE KIT-DISPOSABLE | Acumed Instruments Corp. | Aug 16, 1979 | SESE |
| K771732 | THORNTON ANTERIOR CHAMBER IRRIGATOR | Concept, Inc. | Sep 28, 1977 | SESE |
Top Applicants
- Acumed Instruments Corp. — 1 clearance
- Concept, Inc. — 1 clearance
- Gesco Intl., Inc. — 1 clearance
- Ipax, Inc. — 1 clearance
- Jedmed Instrument Co. — 1 clearance
