Nucleotome L Kit
FDA 510(k) K942987 · Surgical Dynamics, Inc.
510(k) numberK942987
Submission
- Device name
- Nucleotome L Kit
- Applicant
- Surgical Dynamics, Inc.
Concord, CA, US - Received
- June 20, 1994
- Decision date
- October 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GET – Motor, Surgical Instrument, Pneumatic Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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More from United States Surgical, A Division of Tyco Healthc
| 510(k) | Device | Decision |
|---|---|---|
| K960046 | Surgical Dynamics 30K Working Channel ScopeHRX · Traditional | 04/02/1996SE |
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| K950495 | Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000BTA · Traditional | 05/09/1995SE |
| K931109 | Nucleotome E KitHRX · Traditional | 03/29/1994SN |
| K921950 | Surgical Dynamics Discography SystemFMI · Traditional | 06/07/1993SEKD |
| K923525 | Nucleotome 3.5 MM Automated Percutaneous LumbarHRX · Traditional | 02/09/1993SE |
| K914282 | Nucleotome(R) II (VERSION2) Tissue Aspira/CutterHRX · Traditional | 12/19/1991SE |
| K913145 | Nucleotome Tissue Aspirator/CutterHRX · Traditional | 12/19/1991SE |
| K902778 | Surgical Dynamics Nucleotome II Tissue Aspir/CuterHRX · Traditional | 10/30/1990SE |
| K894336 | Surgical Dynamics Discography System · Traditional | 08/04/1989SEKD |
Questions and answers
When was Nucleotome L Kit cleared by the FDA?
Nucleotome L Kit (K942987) received a 510(k) decision of Substantially Equivalent on October 30, 1995, 497 days after the submission was received.
What is the product code of K942987?
The FDA product code is GET – Motor, Surgical Instrument, Pneumatic Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.