Trucone Rotational Cone Biopsy Instrument, Model 231812 - 233018
FDA 510(k) K002042 · New England Medical Corp.
510(k) numberK002042
Submission
- Device name
- Trucone Rotational Cone Biopsy Instrument, Model 231812 - 233018
- Applicant
- New England Medical Corp.
Walden, NY, US - Received
- July 5, 2000
- Decision date
- February 1, 2001
- 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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| 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 |
| 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 |
More from R-Group Intl.
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|---|---|---|
| K931982 | New England Medical Grounding PadGEI · Traditional | 10/05/1993SE |
Questions and answers
When was Trucone Rotational Cone Biopsy Instrument, Model 231812 - 233018 cleared by the FDA?
Trucone Rotational Cone Biopsy Instrument, Model 231812 - 233018 (K002042) received a 510(k) decision of Substantially Equivalent on February 1, 2001, 211 days after the submission was received.
What is the product code of K002042?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.