Endocervical Electrode # 2
FDA 510(k) K070877 · Modern Medical Equipment Mfg., Ltd.
510(k) numberK070877
Submission
- Device name
- Endocervical Electrode # 2
- Applicant
- Modern Medical Equipment Mfg., Ltd.
Richmond, VA, US - Received
- March 29, 2007
- Decision date
- July 27, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K022593 | Thomas Medical ElectrodesHGI · Traditional | Thomas Medical, Inc. | 11/01/2002SE |
| K003608 | Sovereign Bipolar Instruments for GynecologyHGI · Traditional | Aesculap, Inc. | 02/20/2001SE |
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| K993527 | Loop Electrode, Ball ElectrodeHGI · Traditional | Palm Medical USA, Inc. | 07/06/2000SE |
| K993777 | Disposable and Reusable Ball and Loop ElectrodesHGI · Traditional | R-Group Intl. | 05/25/2000SE |
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| 510(k) | Device | Decision |
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| K093479 | Disposable Suction and Irrigation SystemFHF · Traditional | 05/19/2010SE |
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| K070812 | Disposable Laparoscopic InstrumentGEI · Special | 09/14/2007SE |
| K050842 | Agcel Wound Dressing,Agcel Burn DressingFRO · Traditional | 08/02/2006SE |
| K043036 | Non-Stick ElectrodeGEI · Traditional | 05/06/2005SE |
| K033095 | Smoke Evacuation AttachementGEI · Traditional | 11/17/2004SE |
| K040238 | Softseal HSG CatheterLKF · Traditional | 06/22/2004SE |
| K032327 | Modern Medical Bipolar ForcepsGEI · Traditional | 06/15/2004SE |
| K030831 | Lapascopic Instruments and Electrode TipsGEI · Traditional | 06/15/2004SE |
| K033003 | Suction CoagulatorGEI · Traditional | 05/13/2004SE |
Questions and answers
When was Endocervical Electrode # 2 cleared by the FDA?
Endocervical Electrode # 2 (K070877) received a 510(k) decision of Substantially Equivalent on July 27, 2007, 120 days after the submission was received.
What is the product code of K070877?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.