Leep System 6000 Electrosurgical Unit and Accessor
FDA 510(k) K905747 · Coopervision Surgical
510(k) numberK905747
Submission
- Device name
- Leep System 6000 Electrosurgical Unit and Accessor
- Applicant
- Coopervision Surgical
Mountain View, CA, US - Received
- December 24, 1990
- Decision date
- September 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGI – Electrocautery, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4120
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202915 | IRIS Thermocoagulator and Digital ColposcopeHGI · Traditional | Liger Medical, LLC | 04/23/2021SE |
| K152843 | Liger Medical HTU-110HGI · Traditional | Liger Medical, LLC | 06/24/2016SE |
| K130606 | Fmwand Ferromagnetic Surgical SystemHGI · Traditional | Domain Surgical, Inc. | 01/03/2014SE |
| K121881 | Domain Surgical SystemHGI · Traditional | Domain Surgical, Inc. | 10/18/2012SE |
| K070877 | Endocervical Electrode # 2HGI · Traditional | Modern Medical Equipment Mfg., Ltd. | 07/27/2007SE |
| K061651 | Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158HGI · Traditional | Apple Medical Corp. | 10/20/2006SE |
| K022593 | Thomas Medical ElectrodesHGI · Traditional | Thomas Medical, Inc. | 11/01/2002SE |
| K003608 | Sovereign Bipolar Instruments for GynecologyHGI · Traditional | Aesculap, Inc. | 02/20/2001SE |
| K002042 | Trucone Rotational Cone Biopsy Instrument, Model 231812 - 233018HGI · Traditional | New England Medical Corp. | 02/01/2001SE |
| K993527 | Loop Electrode, Ball ElectrodeHGI · Traditional | Palm Medical USA, Inc. | 07/06/2000SE |
More from Palm Medical USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921390 | Xenon Light Source and AccessoriesGCT · Traditional | 07/27/1992SE |
Questions and answers
When was Leep System 6000 Electrosurgical Unit and Accessor cleared by the FDA?
Leep System 6000 Electrosurgical Unit and Accessor (K905747) received a 510(k) decision of Substantially Equivalent on September 17, 1991, 267 days after the submission was received.
What is the product code of K905747?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.