Surg-A-Stat Vasectomy Tip
FDA 510(k) K840370 · Suncoast Medical Manufacturers, Inc.
510(k) numberK840370
Submission
- Device name
- Surg-A-Stat Vasectomy 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
- GET – Motor, Surgical Instrument, Pneumatic Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K942987 | Nucleotome L KitGET · Traditional | Surgical Dynamics, Inc. | 10/30/1995SE |
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| K952463 | GS & GS20 Surgical Tool SystemGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 07/17/1995SE |
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| K914753 | Auto Suture(R) Articulating Endoscopic ClampGET · Traditional | United States Surgical, A Division of Tyco Healthc | 06/11/1992SE |
| K910071 | Porta Gas Compressed Gas Cylinder CartGET · Traditional | Sen Tech Medical Corp. | 03/22/1991SE |
More from Sen Tech Medical Corp.
| 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 |
| K840377 | Surg-A-Stat Cardiovascular TipGEI · Traditional | 07/23/1984SE |
| K840375 | Surg-A-Stat Loop Tip 15GEI · Traditional | 07/23/1984SE |
| K841589 | C-LiteKYT · Traditional | 05/22/1984SE |
Questions and answers
When was Surg-A-Stat Vasectomy Tip cleared by the FDA?
Surg-A-Stat Vasectomy Tip (K840370) 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 K840370?
The FDA product code is GET – Motor, Surgical Instrument, Pneumatic Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.