GCB · Needle, Catheter
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GCB |
|---|---|
| Device Name | Needle, Catheter |
| 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 |
|---|---|---|---|---|
| K150800 | Valved Safety Centesis Catheter | B.Braun Medical, Inc. | Nov 12, 2015 | SESE |
| K974146 | PARACENTESIS CATHETER DEVICE | Allegiance Healthcare Corp. | Jan 28, 1998 | SESE |
| K930568 | ADAIR/VERESS NEEDLE INTRODUCER SET | Medical Dynamics, Inc. | Jul 22, 1993 | SESE |
| K923028 | TURKEL PNEUMOTHORAX KIT | Symbiosis Corp. | Aug 4, 1992 | SESE |
| K900374 | ADAIR/VERESS NEEDLE INTRODUCER SET | Medical Dynamics, Inc. | Apr 20, 1990 | SESE |
| K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES | Concord Laboratories, Inc. | Nov 13, 1985 | SESE |
| K852428 | MANAN EPIDURAL NEEDLE | Manan Manufacturing Co., Inc. | Jun 27, 1985 | SESE |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | Jelco Laboratories | Aug 23, 1978 | SESE |
Top Applicants
- Medical Dynamics, Inc. — 2 clearances
- Symbiosis Corp. — 1 clearance
- Manan Manufacturing Co., Inc. — 1 clearance
- Jelco Laboratories — 1 clearance
- Concord Laboratories, Inc. — 1 clearance
