Accessories(Probes, Suction Tubes, Etc.)
FDA 510(k) K812198 · Reznik Instruments
510(k) numberK812198
Submission
- Device name
- Accessories(Probes, Suction Tubes, Etc.)
- Applicant
- Reznik Instruments
Mchenry, IL, US - Received
- August 4, 1981
- Decision date
- September 11, 1981
- 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 |
|---|---|---|
| K812205 | ForcepGEN · Traditional | 10/26/1981SE |
| K812201 | Photographic EquipmentFEM · Traditional | 10/19/1981SE |
| K812206 | LaparoscopeHET · Traditional | 10/13/1981SE |
| K812204 | Uterine ManipulatorsKOH · Traditional | 10/13/1981SE |
| K812203 | Electrosurgical UnitGEI · Traditional | 10/13/1981SE |
| K812199 | Trocar & Trocar SleevesHET · Traditional | 10/13/1981SE |
| K812202 | Fiber Optic Light SourceHIH · Traditional | 09/29/1981SE |
| K812200 | InsufflatorHIF · Traditional | 09/29/1981SE |
Questions and answers
When was Accessories(Probes, Suction Tubes, Etc.) cleared by the FDA?
Accessories(Probes, Suction Tubes, Etc.) (K812198) received a 510(k) decision of Substantially Equivalent on September 11, 1981, 38 days after the submission was received.
What is the product code of K812198?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.