Fine Needle Aspiration Device
FDA 510(k) K841275 · Gyneco, Inc.
510(k) numberK841275
Submission
- Device name
- Fine Needle Aspiration Device
- Applicant
- Gyneco, Inc.
Mchenry, IL, US - Received
- March 27, 1984
- Decision date
- August 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRM – Compressor, Cardiac, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5200
- Specialty
- Cardiovascular
Other 510(k)s with product code DRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | Zoll Circulation, Inc. | 03/09/2023SE |
| K211289 | RMU-2000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 11/09/2021SE |
| K173553 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 02/08/2018SE |
| K161768 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 11/09/2016SE |
| K153628 | ROSC-U Mini Chest Compressor (RMCC)DRM · Traditional | Resuscitation International, LLC | 01/30/2016SE |
| K141809 | RMU-1000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 10/27/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | Zoll Circulation | 03/15/2012SE |
| K102068 | Miniaturize Chest Compressor (MCC)DRM · Traditional | Resuscitation International | 11/16/2010SE |
| K090422 | Lucas 2DRM · Traditional | Jolife AB | 06/17/2009SE |
| K072527 | Autopulse Resuscitation System, Model 100DRM · Traditional | Zoll Circulation | 03/19/2008SE |
More from Zoll Circulation
| 510(k) | Device | Decision |
|---|---|---|
| K861409 | Syncare Temporary Cardiac Pacing WireLDF · Traditional | 05/05/1986SE |
| K853216 | Master Endomet Biopsy Kit W/Plas Cure 3,4MM-4003,4HHK · Traditional | 04/02/1986SE |
| K852357 | Gyne-Shear Cervical Biopsy Instrument W/Dispis TipHFB · Traditional | 07/05/1985SE |
| K843941 | EndocyteHFE · Traditional | 02/25/1985SE |
Questions and answers
When was Fine Needle Aspiration Device cleared by the FDA?
Fine Needle Aspiration Device (K841275) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 143 days after the submission was received.
What is the product code of K841275?
The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.