Aspiration/Injection Needle
FDA 510(k) K913992 · Northgate Technologies, Inc.
510(k) numberK913992
Submission
- Device name
- Aspiration/Injection Needle
- Applicant
- Northgate Technologies, Inc.
Arlington Heights, IL, US - Received
- September 5, 1991
- Decision date
- October 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K102274 | Arvik Laparoscopic Aspiration InstrumentGAA · Traditional | Arvik Enterprises/ Mini Lap Technologies | 06/15/2011SE |
| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
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| K974741 | Manan Accura NeedleGAA · Traditional | Medical Device Technologies, Inc. | 01/08/1998SE |
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Questions and answers
When was Aspiration/Injection Needle cleared by the FDA?
Aspiration/Injection Needle (K913992) received a 510(k) decision of Substantially Equivalent on October 30, 1991, 55 days after the submission was received.
What is the product code of K913992?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.