Neurotips(Tm)
FDA 510(k) K871571 · Ulster Scientific, Inc.
510(k) numberK871571
Submission
- Device name
- Neurotips(Tm)
- Applicant
- Ulster Scientific, Inc.
Highland, NY, US - Received
- April 22, 1987
- Decision date
- June 18, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143068 | Medical Monofilament Sensory Screening TooolGXB · Traditional | Medical Monofilament Manufacturing | 01/14/2015SE |
| K933798 | Nu-Prep GelGXB · Traditional | Cadwell Laboratories, Inc. | 04/22/1994SE |
| K801907 | AlgesiometerGXB · Traditional | Rowan Products, Inc. | 09/16/1980SE |
| K772406 | AesthesiometerGXB · Traditional | Fred Sammons, Inc. | 01/06/1978SE |
| K771847 | Temp-TesterGXB · Traditional | Jablecki, Charles, Dr. | 11/02/1977SE |
| K761133 | AesthesiometerGXB · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942620 | Feather-Touch Single-Stick DeviceFMK · Traditional | 06/22/1994SE |
| K920562 | UnistikFMK · Traditional | 03/27/1992SE |
| K902592 | Epc Electronic Pipetting SystemJQW · Traditional | 07/19/1990SE |
| K895890 | AutopenFMF · Traditional | 02/16/1990SE |
| K894474 | The Autolet LiteFMK · Traditional | 08/18/1989SE |
| K885340 | Air Displacement PipetteJQW · Traditional | 02/14/1989SE |
| K875354 | Unistep Capillary Blood Collection SystemLCP · Traditional | 02/17/1988SE |
| K871076 | WinpetteJPH · Traditional | 03/23/1987SE |
| K870078 | Accupen(R)FMF · Traditional | 03/17/1987SE |
| K864761 | Usi Autoject Insulin SyringeFMF · Traditional | 12/16/1986SE |
Questions and answers
When was Neurotips(Tm) cleared by the FDA?
Neurotips(Tm) (K871571) received a 510(k) decision of Substantially Equivalent on June 18, 1987, 57 days after the submission was received.
What is the product code of K871571?
The FDA product code is GXB – Esthesiometer, a Class I (low risk) device regulated under 21 CFR 882.1500.