Wiltek Electrocautery Adaptor
FDA 510(k) K914131 · Wiltek Medical, Inc.
510(k) numberK914131
Submission
- Device name
- Wiltek Electrocautery Adaptor
- Applicant
- Wiltek Medical, Inc.
Winston-Salem, NC, US - Received
- September 13, 1991
- Decision date
- September 25, 1991
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K990231 | Wiltek Hot Biopsy ForcepsKGE · Traditional | 04/13/1999SE |
| K922989 | Wiltek Irrigaiton/Aspiration Tube SetBYY · Traditional | 02/15/1994SE |
| K930419 | Wiltek Biopsy ForcepsBWH · Traditional | 06/01/1993SE |
| K914882 | Wiltek Balloon Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914881 | Wiltek Laparoscopic Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914132 | Wiltek Electrocautery Active CordGEI · Traditional | 09/25/1991SE |
| K912288 | Wiltek Standard Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K912122 | Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K910334 | Electrocautery ProbeGEI · Traditional | 02/21/1991SE |
| K894871 | Wiltek Biliary Stent SetFGE · Traditional | 12/21/1989SE |
Questions and answers
When was Wiltek Electrocautery Adaptor cleared by the FDA?
Wiltek Electrocautery Adaptor (K914131) received a 510(k) decision of Substantially Equivalent on September 25, 1991, 12 days after the submission was received.
What is the product code of K914131?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.