Introducer for Endotracheal Tube
FDA 510(k) K820451 · Imed Corp.
510(k) numberK820451
Submission
- Device name
- Introducer for Endotracheal Tube
- Applicant
- Imed Corp.
Walker, MI, US - Received
- February 18, 1982
- Decision date
- March 26, 1982
- 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 |
| K880319 | Magill ForcepsBWB · Traditional | Eastmed Enterprises, Inc. | 03/21/1988SE |
| 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 |
More from Imm Enterprises , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K960512 | Gemini Pc-ItxFRN · Traditional | 11/21/1996SE |
| K953896 | The Imed Ambulatory Infusion Pump, Administration SetsFRN · Traditional | 03/20/1996SE |
| K950153 | Vented/Nonvented Gemini Administration Set with Check Valve and Two Safsite(Tm) ValvesFPA · Traditional | 08/24/1995SE |
| K951922 | Administration Sets with Ball FloatFPA · Traditional | 07/19/1995SE |
| K950419 | The Imed Orion Infusion Pump and Administration SetsFRN · Traditional | 06/21/1995SE |
| K944320 | Vented/Non-Vented Gemini Administration SetFPA · Traditional | 02/14/1995SE |
| K945070 | Versasae Plastic Cannula- 11 GaugeFPA · Traditional | 01/13/1995SE |
| K931173 | Primary Admin Set W/Univ Sp-Man Below/Abv Pump CHFPA · Traditional | 04/15/1994SE |
| K933144 | Gemini Volumetric Infusion Pump/ControllerFRN · Traditional | 10/12/1993SE |
| K924718 | Shrouded Needle DevicesFPA · Traditional | 06/18/1993SE |
Questions and answers
When was Introducer for Endotracheal Tube cleared by the FDA?
Introducer for Endotracheal Tube (K820451) received a 510(k) decision of Substantially Equivalent on March 26, 1982, 36 days after the submission was received.
What is the product code of K820451?
The FDA product code is BWB – Forceps, Tube Introduction, a Class I (low risk) device regulated under 21 CFR 868.5780.