Needle Guide Model 21285A
FDA 510(k) K830753 · Hewlett-Packard Co.
510(k) numberK830753
Submission
- Device name
- Needle Guide Model 21285A
- Applicant
- Hewlett-Packard Co.
Walker, MI, US - Received
- March 10, 1983
- Decision date
- June 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFL – Instrument, Ultrasonic Surgical
- Device class
- Unclassified
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| K233036 | Ultrasonic Surgical SystemLFL · Traditional | Hunan Handlike Minimally Invasive Surgery Co.… | 06/18/2024SE |
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| K231117 | neXus Ultrasonic Surgical Aspirator SystemLFL · Special | Misonix, LLC, A Bioventus Company | 06/23/2023SE |
| K221790 | HARMONIC 700 ShearsLFL · Traditional | Ethicon Endo-Surgery, LLC | 02/28/2023SE |
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Questions and answers
When was Needle Guide Model 21285A cleared by the FDA?
Needle Guide Model 21285A (K830753) received a 510(k) decision of Substantially Equivalent on June 16, 1983, 98 days after the submission was received.
What is the product code of K830753?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.