Retrobulbar Needle
FDA 510(k) K873848 · Healthtek, Inc.
510(k) numberK873848
Submission
- Device name
- Retrobulbar Needle
- Applicant
- Healthtek, Inc.
Nevada City, CA, US - Received
- September 22, 1987
- Decision date
- October 23, 1987
- 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
Other 510(k)s with product code GDM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071732 | MarrowminerGDM · Traditional | Stemcor Systems, Inc. | 09/24/2007SE |
| 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 |
| 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 |
|---|---|---|
| K923448 | Empty Solution Transfer Container W/ Detach LegKPE · Traditional | 07/28/1993SE |
| K913985 | Transfer-Aid(Tm)LHI · Traditional | 03/18/1992SE |
| K913608 | SnapperKPE · Traditional | 11/29/1991SE |
| K881590 | Adfuse(Tm)FRN · Traditional | 05/23/1988SE |
| K874495 | Adcomp 4000 HP SystemLHI · Traditional | 02/16/1988SE |
| K860610 | AdcompLHI · Traditional | 07/08/1986SE |
| K860372 | Fast Flow XX (Aqueous Solution Filter)FPB · Traditional | 05/30/1986SE |
| K854008 | StatlockLHI · Traditional | 11/13/1985SE |
Questions and answers
When was Retrobulbar Needle cleared by the FDA?
Retrobulbar Needle (K873848) received a 510(k) decision of Substantially Equivalent on October 23, 1987, 31 days after the submission was received.
What is the product code of K873848?
The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.