Tbi Needle
FDA 510(k) K860582 · Hobbs Medical, Inc.
510(k) numberK860582
Submission
- Device name
- Tbi Needle
- Applicant
- Hobbs Medical, Inc.
Stafford Springs, CT, US - Received
- February 18, 1986
- Decision date
- March 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
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| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
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| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
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|---|---|---|
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| K093079 | Touchsoft Coagulator with Banana Fitting, Model 4581 and with Universal Fitting, Model…KNS · Traditional | 08/02/2010SE |
| K030765 | Hobbs Mistifier Spray CatheterOCX · Traditional | 06/09/2003SE |
| K933354 | Hobbs Medical Cleaning BrushFEB · Traditional | 10/28/1993SE |
| K922396 | Fujinon Forceps -- ModificationFCL · Traditional | 12/10/1992SE |
| K921026 | Pressure GaugeKNT · Traditional | 04/24/1992SE |
| K914358 | Encapsulated Guidewire with Flexible TipEYB · Traditional | 11/19/1991SE |
| K893729 | Hobbs Medical Microbiology BrushFDX · Traditional | 08/28/1989SE |
| K872509 | Linden Stone Extraction BalloonFGE · Traditional | 09/22/1987SE |
Questions and answers
When was Tbi Needle cleared by the FDA?
Tbi Needle (K860582) received a 510(k) decision of Substantially Equivalent on March 4, 1986, 14 days after the submission was received.
What is the product code of K860582?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.