Single Use Lee Electrode
FDA 510(k) K913213 · Aspen Laboratories, Inc.
510(k) numberK913213
Submission
- Device name
- Single Use Lee Electrode
- Applicant
- Aspen Laboratories, Inc.
Englewood, CO, US - Received
- July 19, 1991
- Decision date
- February 13, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HGI – Electrocautery, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4120
- Specialty
- Obstetrics/Gynecology
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| K955834 | System 6500 Abc Electrosurgical UnitGEI · Traditional | 07/11/1996SE |
| K960296 | 4000 EtmGEI · Traditional | 02/20/1996SE |
| K953081 | Beamer PlusGEI · Traditional | 10/30/1995SE |
| K953007 | Excalibur Plus Electrosurgical UnitGEI · Traditional | 08/21/1995SE |
| K946104 | Smokievac Electrosurgical PencilGEI · Traditional | 04/03/1995SE |
| K944012 | Electrosurgical Flexible Electrode In-Line Suction CoagulatorGEI · Traditional | 12/21/1994SE |
| K924960 | Excalibur Electrosurgical UnitGEI · Traditional | 04/16/1993SE |
| K896838 | Bistat Electrosurgical Unit 60-5400-001GEX · Traditional | 02/13/1990SE |
Questions and answers
When was Single Use Lee Electrode cleared by the FDA?
Single Use Lee Electrode (K913213) received a 510(k) decision of Substantially Equivalent on February 13, 1992, 209 days after the submission was received.
What is the product code of K913213?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.