Wells Johnson Weco Monopolar/Frazier Suction Probe
FDA 510(k) K945805 · Wells Johnson Co.
510(k) numberK945805
Submission
- Device name
- Wells Johnson Weco Monopolar/Frazier Suction Probe
- Applicant
- Wells Johnson Co.
Tucson, AZ, US - Received
- November 28, 1994
- Decision date
- December 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|
| K991437 | Wells Johnson Infusion System, Model 20-6000-00FRN · Traditional | 08/30/1999SE |
| K984448 | Bircoll Balloon DissectorFZW · Traditional | 01/28/1999SE |
| K971580 | Uas Ultrasonic Aspirator SystemLFL · Traditional | 12/09/1997SE |
| K945876 | Weco Endoscopic System with Fiber Optic LightEQH · Traditional | 12/04/1995SE |
| K945500 | Wells Johnson Fixation SystemJEY · Traditional | 09/21/1995SE |
| K951519 | Weco Endoscopic System with Fiber Optic LightFWL · Traditional | 06/14/1995SE |
| K945877 | Weco Endoscopic Systems with Fiber Optic LightHJM · Traditional | 03/02/1995SE |
| K854068 | External Mechanical Fastener · Traditional | 11/22/1985SE |
| K843188 | Wells Johnson Co. Chaj-Chir-Suction TipJOL · Traditional | 09/20/1984SE |
| K832521 | Plastic Suction TipsGEA · Traditional | 10/20/1983SE |
Questions and answers
When was Wells Johnson Weco Monopolar/Frazier Suction Probe cleared by the FDA?
Wells Johnson Weco Monopolar/Frazier Suction Probe (K945805) received a 510(k) decision of Substantially Equivalent on December 13, 1994, 15 days after the submission was received.
What is the product code of K945805?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.