Illinois Sternal/Iliac Aspiration Needle
FDA 510(k) K930160 · Symbiosis Corp.
510(k) numberK930160
Submission
- Device name
- Illinois Sternal/Iliac Aspiration Needle
- Applicant
- Symbiosis Corp.
Miami, FL, US - Received
- January 13, 1993
- Decision date
- July 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDM – Needle, Aspiration And Injection, Reusable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K971114 | Bioaccess Marrow Harvest SystemGDM · Traditional | Bioaccess, Inc. | 06/03/1997SE |
| K953082 | Iliac Crest Bone Marrow Aspiration NeedleGDM · Traditional | Baxter Healthcare Corp | 09/22/1995SE |
| K953064 | Bioaccess Marrow Harvest SystemGDM · Traditional | Bioaccess, Inc. | 08/07/1995SE |
| K936207 | Endo-Needle InstrumentGDM · Traditional | Gerard Medical, Inc. | 06/16/1994SE |
| K923872 | Bone Marrow Biopsy SystemGDM · Traditional | The Straumann Co. | 12/15/1992SE |
| K915572 | Becton Dickinson Modified Menghini NeedleGDM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/03/1992SE |
| K904667 | Na NeedlesGDM · Traditional | Olympus Corp. | 12/12/1990SE |
| K903750 | Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
| K903749 | Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
More from Downs Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K955119 | Symbiosis Monopolar Electrosurgical Roller ElectrodesHIH · Traditional | 01/18/1996SE |
| K953453 | Symbiosis Monopolar Electrosurgical Roller ElectrodesFAS · Traditional | 01/17/1996SE |
| K953242 | Symbiosis Monoplar Electrosurgical ElectrodesKNF · Traditional | 10/06/1995SE |
| K952432 | Symbiosis Bipolar ForcepsGEI · Traditional | 07/05/1995SE |
| K951387 | Symbiosis Bipolar ScissorsGCJ · Traditional | 04/10/1995SE |
| K950286 | Symbiosis Bipolar ScissorsGCJ · Traditional | 02/03/1995SE |
| K946238 | Symbiosis Gastrointestinal Biopsy ForcepsFCL · Traditional | 01/20/1995SE |
| K930773 | Symbiosis Gynecological Biopsy ForcepsHFB · Traditional | 07/28/1994SE |
| K941426 | Symbiosis Reusable Monopolar Electrosurgical ProbeGEI · Traditional | 06/22/1994SE |
| K932266 | Symbiosis Dispos Gastro Biopsy Forceps W/Reuse HanKGE · Traditional | 03/15/1994SE |
Questions and answers
When was Illinois Sternal/Iliac Aspiration Needle cleared by the FDA?
Illinois Sternal/Iliac Aspiration Needle (K930160) received a 510(k) decision of Substantially Equivalent on July 6, 1993, 174 days after the submission was received.
What is the product code of K930160?
The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.