Spinal Needle
FDA 510(k) K882073 · Karlin Technology, Inc.
510(k) numberK882073
Submission
- Device name
- Spinal Needle
- Applicant
- Karlin Technology, Inc.
Marina Del Rey, CA, US - Received
- May 17, 1988
- Decision date
- July 18, 1988
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K903969 | Suction Retractor(Tower Attach.)For Crank Fram RetGAD · Traditional | 09/05/1990SE |
| K893203 | Bone ScrewJDR · Traditional | 04/04/1990SE |
| K893201 | Bone PlateHRS · Traditional | 04/04/1990SE |
| K882525 | Spinal MicroknifeHTS · Traditional | 09/22/1988SE |
| K882519 | X-Ray MarkerJAC · Traditional | 08/09/1988SE |
| K882520 | Shoulder Bolster, Knee, Ankle & Leg Support PadsLWG · Traditional | 07/18/1988SE |
| K882524 | Universally Adjustable ArmboardBTX · Traditional | 07/08/1988SE |
| K882077 | Microdiscectomy CurrettesLXH · Traditional | 06/17/1988SE |
| K882072 | Orthopaedic and Spinal Ring CurrettesJXH · Traditional | 06/17/1988SE |
| K882069 | Spinal Distractors, SpannersLXH · Traditional | 06/17/1988SE |
Questions and answers
When was Spinal Needle cleared by the FDA?
Spinal Needle (K882073) received a 510(k) decision of Substantially Equivalent on July 18, 1988, 62 days after the submission was received.
What is the product code of K882073?
The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.