Needle Guide
FDA 510(k) K943863 · Biopsys Medical, Inc.
510(k) numberK943863
Submission
- Device name
- Needle Guide
- Applicant
- Biopsys Medical, Inc.
San Juan Capistrano, CA, US - Received
- August 8, 1994
- Decision date
- December 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
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| K951229 | Modified Biopsy NeedleKNW · Traditional | 04/06/1995SE |
| K950006 | Surgical Staple MarkerGDW · Traditional | 03/15/1995SE |
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Questions and answers
When was Needle Guide cleared by the FDA?
Needle Guide (K943863) received a 510(k) decision of Substantially Equivalent on December 29, 1994, 143 days after the submission was received.
What is the product code of K943863?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.