510(k)
K162710: Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
FDA 510(k) · Tgs Medical Co., Ltd. · decided Feb 9, 2017
Key facts
| 510(k) number | K162710 |
|---|---|
| Device name | Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload |
| Applicant | Tgs Medical Co., Ltd. |
| Product code | GDW |
| Date received | Sep 28, 2016 |
| Decision date | Feb 9, 2017 |
| Decision | Substantially equivalent (SESE) |
| Submission type | Traditional |
| Review panel | General & Plastic Surgery |
| Medical specialty | General & Plastic Surgery |
At a glance
- None MAUDE adverse event reports
- None Recall events
- None UDI device identifiers (GUDID)
- 1–9 Predicate devices cited
- None Later submissions citing this device
- 100–999 510(k)s with this product code
- Yes 510(k) summary on file
- No 510(k) statement on file
- Not listed On the FDA AI-enabled device list
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
Reading a 510(k)
- Decision
- SESE means the FDA found the device substantially equivalent to its predicate, so it may be marketed in the United States.
- Predicates
- Each clearance cites one or more legally marketed devices; the chain of predicates shows where a technology came from.
- Product code
- The three-letter code sets the device type, class and regulation, and groups competing clearances.
- Summary or statement
- Applicants file either a 510(k) summary of the safety and effectiveness information or a statement that it is available on request.
About 510(k) premarket notifications
A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database · Source date: