Flowgun Electrocautery Probes
FDA 510(k) K941337 · O.R. Concepts, Inc.
510(k) numberK941337
Submission
- Device name
- Flowgun Electrocautery Probes
- Applicant
- O.R. Concepts, Inc.
Burnsville, MN, US - Received
- March 21, 1994
- Decision date
- August 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K935971 | Flowgun Electrocautery ProbesGEI · Traditional | 05/16/1994SE |
| K935970 | Flowgun Electrocautery Probe HandleGEI · Traditional | 05/16/1994SE |
| K935645 | Flowgun Reusable Irrigation ProbesGCJ · Traditional | 03/07/1994SE |
| K926242 | Orc Endoscopic Monopolar Electrosurgical ProbeGEI · Traditional | 10/15/1993SE |
| K922244 | Insufflator Tubing/Filter KitHIF · Traditional | 09/24/1993SE |
| K922197 | Insufflator Tubing KitHIG · Traditional | 09/24/1993SE |
| K932449 | Dr. FogOCT · Traditional | 08/11/1993SE |
| K925147 | Orc 10.0MM Suction ProbeGCJ · Traditional | 06/25/1993SE |
| K925024 | Orc Tappered Irrigating ProbeGCY · Traditional | 05/21/1993SE |
| K923908 | # 9455 and #9457 Poole Tip Suction ProbeGCY · Traditional | 05/17/1993SE |
Questions and answers
When was Flowgun Electrocautery Probes cleared by the FDA?
Flowgun Electrocautery Probes (K941337) received a 510(k) decision of Substantially Equivalent on August 17, 1994, 149 days after the submission was received.
What is the product code of K941337?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.