Disposable and Reusable Ball and Loop Electrodes
FDA 510(k) K993777 · R-Group Intl.
510(k) numberK993777
Submission
- Device name
- Disposable and Reusable Ball and Loop Electrodes
- Applicant
- R-Group Intl.
Gainesville, FL, US - Received
- November 8, 1999
- Decision date
- May 25, 2000
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K001233 | Acti-Flex Fluid Delivery System or Acti-Flex F D SFPA · Traditional | 12/13/2000SE |
| K001599 | Acti-Flex IV Administration SetFPA · Traditional | 09/18/2000SE |
| K952470 | Acti-Flex Low, Medium, Rescare I, Rescare Ii.GCD · Traditional | 11/28/1995SE |
| K954035 | Acti-Flex Arterial Extension SetCBT · Traditional | 09/25/1995SE |
| K940319 | R-Group International Coiled Low Pressure Extension LineFPA · Traditional | 11/10/1994SE |
| K913267 | R-Group Intl. One Wall Puncture NeedleDRC · Traditional | 06/05/1992SE |
Questions and answers
When was Disposable and Reusable Ball and Loop Electrodes cleared by the FDA?
Disposable and Reusable Ball and Loop Electrodes (K993777) received a 510(k) decision of Substantially Equivalent on May 25, 2000, 199 days after the submission was received.
What is the product code of K993777?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.