Islam Sternal Puncture Needle, Cat # AF-594-00-V
FDA 510(k) K903748 · Downs Surgical , Ltd.
510(k) numberK903748
Submission
- Device name
- Islam Sternal Puncture Needle, Cat # AF-594-00-V
- Applicant
- Downs Surgical , Ltd.
Sheffield S9 4wj, GB - Received
- August 16, 1990
- Decision date
- October 31, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K936207 | Endo-Needle InstrumentGDM · Traditional | Gerard Medical, Inc. | 06/16/1994SE |
| K930160 | Illinois Sternal/Iliac Aspiration NeedleGDM · Traditional | Symbiosis Corp. | 07/06/1993SE |
| 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 |
More from Downs Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K903750 | Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional | 10/31/1990SE |
| K903749 | Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional | 10/31/1990SE |
| K903747 | Islam Sternal Puncture Needle, Cat # AG-592-00-UGDM · Traditional | 10/31/1990SE |
| K900616 | Shepperd Cutting ForcepsHRX · Traditional | 10/22/1990SE |
| K900615 | Shepperd Nerve Root Retractor W/Suction & FibreHRX · Traditional | 10/22/1990SE |
| K900614 | Shepperd Short Muscle Retractor (GS-501-45-V)HRX · Traditional | 10/22/1990SE |
| K900613 | Shepperd Shelter Tube Complete & DrillHRX · Traditional | 10/22/1990SE |
| K900612 | Shepperd Trephine Set (GS-501-30-V)HRX · Traditional | 10/22/1990SE |
| K900611 | Shepperd Dilatation Tube Set (GS-501-20-H)HRX · Traditional | 10/22/1990SE |
| K900610 | Shepperd Cannula Stillette & Obdurator SetHRX · Traditional | 10/22/1990SE |
Questions and answers
When was Islam Sternal Puncture Needle, Cat # AF-594-00-V cleared by the FDA?
Islam Sternal Puncture Needle, Cat # AF-594-00-V (K903748) received a 510(k) decision of Substantially Equivalent on October 31, 1990, 76 days after the submission was received.
What is the product code of K903748?
The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.