Trans Vaginal Needle Guide
FDA 510(k) K971722 · Protek Medical Products, Inc.
510(k) numberK971722
Submission
- Device name
- Trans Vaginal Needle Guide
- Applicant
- Protek Medical Products, Inc.
Iowa City, IA, US - Received
- May 9, 1997
- Decision date
- July 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
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More from Vitrolife Sweden AB
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|---|---|---|
| K973958 | General Purpose Atl Needle Guide KitITX · Traditional | 01/22/1998SE |
| K973622 | Transducer PositionerITX · Traditional | 11/26/1997SE |
| K970893 | Ultrasound Transducer DrapeFYA · Traditional | 10/20/1997SE |
| K970889 | Ultrasound Transducer DrapeKKX · Traditional | 10/20/1997SE |
| K973362 | Needle Guide/GridITX · Traditional | 10/01/1997SE |
| K970885 | Ultrasound Systems DrapeMMP · Traditional | 09/22/1997SE |
| K970891 | Drape, Surgical-LatexKKX · Traditional | 08/22/1997SE |
| K971115 | GE Medical-Needle Guide for SV, TR Andatf, Acuson-Needle GuideITX · Traditional | 06/13/1997SE |
Questions and answers
When was Trans Vaginal Needle Guide cleared by the FDA?
Trans Vaginal Needle Guide (K971722) received a 510(k) decision of Substantially Equivalent on July 10, 1997, 62 days after the submission was received.
What is the product code of K971722?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.