Reflex(R) Ehs (Endoscopic Hernia Stapler)
FDA 510(k) K933901 · Richard-Allan Medical
510(k) numberK933901
Submission
- Device name
- Reflex(R) Ehs (Endoscopic Hernia Stapler)
- Applicant
- Richard-Allan Medical
Richland, MI, US - Received
- August 10, 1993
- Decision date
- November 19, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAG – Stapler, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4740
- Specialty
- General Hospital
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
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| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0…GAG · Traditional | Covidien, LLC | 07/01/2026SE |
| K251482 | AEON Endoscopic Powered StaplerGAG · Traditional | Lexington Medical, Inc. | 07/11/2025SE |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098)GAG · Traditional | Intuitive Surgical, Inc. | 03/10/2025SE |
| K240881 | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL…GAG · Traditional | Covidien (Part of Medtronic) | 11/01/2024SE |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…GAG · Special | Ethicon Endo-Surgery, LLC | 07/03/2024SE |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler…GAG · Traditional | Lexington Medical, Inc. | 05/07/2024SE |
| K231934 | GIA Stapler with Tri-Staple TechnologyGAG · Traditional | Covidien | 10/27/2023SE |
| K232126 | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler…GAG · Special | Covidien | 08/16/2023SE |
| K231491 | TA Stapler and Loading Unit with DST Series TechnologyGAG · Traditional | Covidien | 08/16/2023SE |
| K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)GAG · Traditional | Covidien | 02/22/2023SE |
More from Covidien
| 510(k) | Device | Decision |
|---|---|---|
| K942207 | Reflex Ins Insufflation NeedleHIF · Traditional | 05/27/1994SE |
| K935105 | Reflex Esp with Finger SwitchesGEI · Traditional | 02/22/1994SE |
| K933508 | Reflex SDD Surgical StaplerGEF · Traditional | 11/23/1993SE |
| K924881 | Reflex(R) EspGEI · Traditional | 07/23/1993SE |
| K924929 | Reflex(R) EcaHBT · Traditional | 07/21/1993SE |
| K905701 | Richard-Allan Sheet ClipKKX · Traditional | 02/19/1991SE |
| K905682 | Richard-Allan Clamp CoversFSM · Traditional | 02/19/1991SE |
Questions and answers
When was Reflex(R) Ehs (Endoscopic Hernia Stapler) cleared by the FDA?
Reflex(R) Ehs (Endoscopic Hernia Stapler) (K933901) received a 510(k) decision of Substantially Equivalent on November 19, 1993, 101 days after the submission was received.
What is the product code of K933901?
The FDA product code is GAG – Stapler, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4740.