Magill Forceps
FDA 510(k) K880319 · Eastmed Enterprises, Inc.
510(k) numberK880319
Submission
- Device name
- Magill Forceps
- Applicant
- Eastmed Enterprises, Inc.
Marlton, NJ, US - Received
- January 26, 1988
- Decision date
- March 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWB – Forceps, Tube Introduction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5780
- Specialty
- Anesthesiology
Other 510(k)s with product code BWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884584 | Tongue Seizing Forceps with & Without Rubber PadsBWB · Traditional | Eastmed Enterprises, Inc. | 11/14/1988SE |
| K880318 | Rovenstein ForcepsBWB · Traditional | Eastmed Enterprises, Inc. | 03/21/1988SE |
| K840313 | Cat. 9 Anesthesiology Respiratory DevBWB · Traditional | Imm Enterprises , Ltd. | 02/04/1984SE |
| K834169 | Op-Con Surgical Instrument #9BWB · Traditional | Imm Enterprises , Ltd. | 01/17/1984SE |
| K820451 | Introducer for Endotracheal TubeBWB · Traditional | Imed Corp. | 03/26/1982SE |
More from Imed Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K922019 | Laryngoscope RigidCCW · Traditional | 01/26/1993SE |
| K921128 | Endotracheal Tube StyletBSR · Traditional | 06/02/1992SE |
| K914741 | Amer Profile Miller Laryngoscope Blades, ModifiedCCW · Traditional | 02/03/1992SE |
| K903618 | Robertazzi Nasopharyngeal AirwayBTQ · Traditional | 01/08/1991SE |
| K901489 | Macintosh Laryngoscope Blades (American Profile)CCW · Traditional | 04/10/1990SE |
| K890342 | Airways (Guedel, Berman & Nasopharyngeal Types)BTO · Traditional | 04/27/1989SE |
| K884584 | Tongue Seizing Forceps with & Without Rubber PadsBWB · Traditional | 11/14/1988SE |
| K884073 | Laryngoscope Blade (Robertshaw Style)CCW · Traditional | 10/13/1988SE |
| K884072 | 15 Millimeter Male and Female AdaptersCAI · Traditional | 10/07/1988SE |
| K882433 | Laryngoscope RigidCCW · Traditional | 09/02/1988SE |
Questions and answers
When was Magill Forceps cleared by the FDA?
Magill Forceps (K880319) received a 510(k) decision of Substantially Equivalent on March 21, 1988, 55 days after the submission was received.
What is the product code of K880319?
The FDA product code is BWB – Forceps, Tube Introduction, a Class I (low risk) device regulated under 21 CFR 868.5780.