TBD
FDA 510(k) K965245 · Utah Medical Products, Inc.
510(k) numberK965245
Submission
- Device name
- TBD
- Applicant
- Utah Medical Products, Inc.
Midvale, UT, US - Received
- December 31, 1996
- Decision date
- July 3, 1997
- 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 |
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| 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 |
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| 510(k) | Device | Decision |
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| K101535 | Bt-CathOQY · Traditional | 01/11/2011SE |
| K063611 | Saline/ Contrast Media Infusion CatheterLKF · Traditional | 05/23/2007SE |
| K001874 | Peripherally Inserted Central CatheterLJS · Traditional | 09/25/2000SE |
| K000974 | Fowler Endocurette, Model Cur-XxxHHK · Traditional | 05/23/2000SE |
| K970077 | Liberty Plus SYSTEM(PFS-300)/VAGINAL Probe, Liberty PLUS(PFS-044)KPI · Traditional | 05/23/1997SE |
| K955663 | Abc In-Line Blood Sampling KitCBT · Traditional | 03/17/1997SE |
| K964526 | Liberty Rectal Pelvic Floor ExerciserKPI · Traditional | 02/10/1997SE |
| K961424 | Intran 500HFN · Traditional | 07/10/1996SE |
Questions and answers
When was TBD cleared by the FDA?
TBD (K965245) received a 510(k) decision of Substantially Equivalent on July 3, 1997, 184 days after the submission was received.
What is the product code of K965245?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.