Terumo Disposable Spinal Needle
FDA 510(k) K760775 · Terumo America, Inc.
510(k) numberK760775
Submission
- Device name
- Terumo Disposable Spinal Needle
- Applicant
- Terumo America, Inc.
Mchenry, IL, US - Received
- October 4, 1976
- Decision date
- November 1, 1976
- 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
Other 510(k)s with product code GAA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223625 | CapnoSpot Pneumothorax Decompression IndicatorGAA · Traditional | Pneumeric, Inc. | 03/28/2023SE |
| K102274 | Arvik Laparoscopic Aspiration InstrumentGAA · Traditional | Arvik Enterprises/ Mini Lap Technologies | 06/15/2011SE |
| K011586 | Irma SL Blood Analysis System GL CartridgeGAA · Traditional | Diametrics Medical, Inc. | 11/16/2001SE |
| K994151 | Percutx-Injection/Aspiration Needle Probes/DevicesGAA · Traditional | Ximed/Prosure/Injectx | 03/01/2000SE |
| K983200 | Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexGAA · Traditional | Ximed/Prosure/Injectx | 12/11/1998SE |
| K974741 | Manan Accura NeedleGAA · Traditional | Medical Device Technologies, Inc. | 01/08/1998SE |
| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
| K961959 | MD Tech Biopsy Set for Bone and Bone MarrowGAA · Traditional | Medical Device Technologies, Inc. | 07/19/1996SE |
| K945109 | Monoject Bone Marrow Biopsy TraysGAA · Traditional | Sherwood Medical Co. | 11/14/1994SE |
| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K811523 | Plasma FlexKSR · Traditional | 09/09/1981SE |
| K802970 | Terumo Hollow Fiber OxygenatorDTZ · Traditional | 01/22/1981SE |
| K802441 | Clirans TH10 Hollow Fiber DialyzerFJI · Traditional | 12/18/1980SE |
| K802122 | Clirans TH13 Hollow Fiber DialyzerFJI · Traditional | 12/18/1980SE |
| K801194 | Clirans TE07 Hollow Fiber DialyzerFJI · Traditional | 08/12/1980SE |
| K801193 | Clirans TE15 Hollow Fiber DialyzerKDJ · Traditional | 08/12/1980SE |
| K801192 | Clirans TE10 Hollow Fiber DialyzerFJI · Traditional | 08/12/1980SE |
| K791411 | Coaxial Dual Flow CatheterKOC · Traditional | 11/13/1979SE |
| K791173 | Surflo Injection PlugFPA · Traditional | 07/30/1979SE |
| K790105 | Terumo ImugardGKT · Traditional | 05/24/1979SE |
Questions and answers
When was Terumo Disposable Spinal Needle cleared by the FDA?
Terumo Disposable Spinal Needle (K760775) received a 510(k) decision of Substantially Equivalent on November 1, 1976, 28 days after the submission was received.
What is the product code of K760775?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.