Surg-A-Stat Cardiovascular Tip
FDA 510(k) K840377 · Suncoast Medical Manufacturers, Inc.
510(k) numberK840377
Submission
- Device name
- Surg-A-Stat Cardiovascular Tip
- Applicant
- Suncoast Medical Manufacturers, Inc.
Mchenry, IL, US - Received
- January 27, 1984
- Decision date
- July 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K841604 | Adjust-A-Temp High TemperatureGEI · Traditional | 12/07/1984SE |
| K841603 | Adjust-A-Temp MicroGEI · Traditional | 12/07/1984SE |
| K841509 | Replace-A-Tip Adjustable High Temp.GEI · Traditional | 12/07/1984SE |
| K841459 | Replace-A-Tip Adjust. Low Temp.-GEI · Traditional | 12/07/1984SE |
| K841591 | Pyro-TipGEI · Traditional | 10/31/1984SE |
| K840376 | Surg-A Stat Loop TipGEI · Traditional | 10/26/1984SE |
| K840387 | Surg-A-Stat Loop Tip 2GEI · Traditional | 07/23/1984SE |
| K840375 | Surg-A-Stat Loop Tip 15GEI · Traditional | 07/23/1984SE |
| K840370 | Surg-A-Stat Vasectomy TipGET · Traditional | 07/23/1984SE |
| K841589 | C-LiteKYT · Traditional | 05/22/1984SE |
Questions and answers
When was Surg-A-Stat Cardiovascular Tip cleared by the FDA?
Surg-A-Stat Cardiovascular Tip (K840377) received a 510(k) decision of Substantially Equivalent on July 23, 1984, 178 days after the submission was received.
What is the product code of K840377?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.