Surg-A Stat Loop Tip
FDA 510(k) K840376 · Suncoast Medical Manufacturers, Inc.
510(k) numberK840376
Submission
- Device name
- Surg-A Stat Loop Tip
- Applicant
- Suncoast Medical Manufacturers, Inc.
Clearwater, FL, US - Received
- January 27, 1984
- Decision date
- October 26, 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).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
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 |
| K840387 | Surg-A-Stat Loop Tip 2GEI · Traditional | 07/23/1984SE |
| K840377 | Surg-A-Stat Cardiovascular TipGEI · 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 Loop Tip cleared by the FDA?
Surg-A Stat Loop Tip (K840376) received a 510(k) decision of Substantially Equivalent on October 26, 1984, 273 days after the submission was received.
What is the product code of K840376?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.