V. Mueller (R) Gooseneck Circular Stapler
FDA 510(k) K862772 · American V. Mueller
510(k) numberK862772
Submission
- Device name
- V. Mueller (R) Gooseneck Circular Stapler
- Applicant
- American V. Mueller
Chicago, IL, US - Received
- July 22, 1986
- Decision date
- August 18, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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.
Other 510(k)s with product code GAG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K873771 | Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional | 12/18/1987SE |
| K873332 | Maxivac(Tm) Closed Wound Suction Drainage SystemGCY · Traditional | 09/08/1987SE |
| K871685 | Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt SysJXG · Traditional | 06/12/1987SE |
| K864676 | Heyer-Schulte Hermetic External CSF Drain. SystemJXG · Traditional | 12/29/1986SE |
| K861471 | V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional | 06/06/1986SE |
| K854568 | V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional | 12/02/1985SE |
| K854049 | Heyer-Schulte Syringo Peritoneal ShuntJXG · Traditional | 11/27/1985SE |
| K851082 | V. Mueller Blom-Singer Esophageal Insufflation TesENW · Traditional | 07/22/1985SE |
| K851974 | V. Mueller Vital Skin StaplerGDT · Traditional | 06/11/1985SE |
| K850947 | V-Mueller Inverted Linear Anastomosis InstrumentsGAG · Traditional | 04/17/1985SE |
Questions and answers
When was V. Mueller (R) Gooseneck Circular Stapler cleared by the FDA?
V. Mueller (R) Gooseneck Circular Stapler (K862772) received a 510(k) decision of Substantially Equivalent on August 18, 1986, 27 days after the submission was received.
What is the product code of K862772?
The FDA product code is GAG – Stapler, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4740.