Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158
FDA 510(k) K061651 · Apple Medical Corp.
510(k) numberK061651
Submission
- Device name
- Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158
- Applicant
- Apple Medical Corp.
Marlboro, MA, US - Received
- June 13, 2006
- Decision date
- October 20, 2006
- 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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| 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 |
| 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 |
| K993777 | Disposable and Reusable Ball and Loop ElectrodesHGI · Traditional | R-Group Intl. | 05/25/2000SE |
More from R-Group Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | 04/26/2005SE |
| K041131 | Apple Medical Ob Mobius Elastic RetractorGCJ · Traditional | 05/13/2004SE |
| K014005 | Apple Medical Mobius Elastic RetractorGCJ · Traditional | 02/15/2002SE |
| K000026 | Apple Medical One-Touch Uterine SamplerHHK · Traditional | 03/31/2000SE |
| K970788 | Pneumo-Matic Insufflation NeedleFHO · Traditional | 03/27/1997SE |
| K961460 | Lweet Cone Biopsy InstrumentHGI · Traditional | 11/19/1996SE |
| K952841 | The AssistantFHA · Traditional | 08/18/1995SE |
| K941506 | Ureteral IlluminatorFCS · Traditional | 10/05/1994SE |
Questions and answers
When was Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158 cleared by the FDA?
Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158 (K061651) received a 510(k) decision of Substantially Equivalent on October 20, 2006, 129 days after the submission was received.
What is the product code of K061651?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.