Eliachar Modified Esophageal Stent
FDA 510(k) K904821 · Hood Laboratories
510(k) numberK904821
Submission
- Device name
- Eliachar Modified Esophageal Stent
- Applicant
- Hood Laboratories
Pembroke, MA, US - Received
- October 24, 1990
- Decision date
- January 14, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ESW – Prosthesis, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3610
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code ESW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | Boston Scientific Corporation | 07/10/2026SE |
| K253327 | HANAROSTENT Esophagus Upper (CCC)ESW · Special | M.I.Tech Co., Ltd. | 10/30/2025SE |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS StentESW · Traditional | Taewoong Medical Co., Ltd. | 10/30/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | Merit Medical Systems, Inc. | 07/23/2025SE |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemESW · Traditional | Boston Scientific | 04/29/2024SE |
| K233837 | Agile Esophageal Stent SystemESW · Traditional | Boston Scientific Corporation | 04/04/2024SE |
| K240522 | Esophageal TTS StentESW · Special | Taewoong Medical | 03/22/2024SE |
| K223266 | Hilzo Esophageal StentsESW · Traditional | Thoracent, Inc. | 01/16/2024SE |
| K221482 | Esophageal TTS StentESW · Special | Taewoong Medical Co., Ltd. | 06/22/2022SE |
| K211960 | Agile Esophageal OTW Stent SystemESW · Traditional | Boston Scientific Corporation | 11/22/2021SE |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K921452 | Acoustic RhinometerBXQ · Traditional | 07/08/1993SE |
| K920994 | Hood Nasal Septal ButtonLFB · Traditional | 05/15/1992SE |
| K905703 | Krupin Eye Valve with DiskKYF · Traditional | 03/15/1991SE |
| K897049 | Gibson Endolymphatic ShuntESZ · Traditional | 03/16/1990SE |
| K897059 | Hood Speaking ValveJOH · Traditional | 03/12/1990SE |
| K893866 | Hood Pediatric Tracheostomy TubeBTO · Traditional | 08/07/1989SE |
| K884810 | Silicone Laryngeal StentFWN · Traditional | 05/10/1989SE |
| K890599 | Hood Nasal SplintEPP · Traditional | 03/17/1989SE |
| K885125 | Krupin Eye Valve W/Scleral BuckleKYF · Traditional | 01/24/1989SE |
| K882430 | Hood Tracheal Stoma ButtonBTO · Traditional | 06/28/1988SE |
Questions and answers
When was Eliachar Modified Esophageal Stent cleared by the FDA?
Eliachar Modified Esophageal Stent (K904821) received a 510(k) decision of Substantially Equivalent on January 14, 1991, 82 days after the submission was received.
What is the product code of K904821?
The FDA product code is ESW – Prosthesis, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 878.3610.