Ceptor Hesive
FDA 510(k) K790269 · Med General
510(k) numberK790269
Submission
- Device name
- Ceptor Hesive
- Applicant
- Med General
Mchenry, IL, US - Received
- February 5, 1979
- Decision date
- February 26, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262654 | Dexus Prosthetic System (MSL2, MSR2)GXY · Special | Zhejiang Qiangnao Technology Co.,Ltd | 08/27/2026SE |
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US)…GXY · Traditional | Ambu A/S | 07/14/2026SE |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayGXY · Abbreviated | Cadwell Industries, Inc. | 06/26/2026SE |
| K261522 | BioWave BioWrapsGXY · Special | Biowave Corporation | 06/03/2026SE |
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)GXY · Traditional | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 05/08/2026SE |
| K254183 | MR Conditional Cup ElectrodesGXY · Traditional | Technomed Europe | 05/07/2026SE |
| K252439 | Tutamen Self Adhesive ElectrodesGXY · Traditional | Dongguan Tutamen Metalwork Co., Ltd. | 05/01/2026SE |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…GXY · Traditional | Otto Bock Healthcare Products GmbH | 04/22/2026SE |
| K260363 | Ceribell Brain Monitor HeadbandGXY · Abbreviated | Ceribell, Inc. | 04/03/2026SE |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)GXY · Special | Bionit Labs Srl | 03/12/2026SE |
More from Bionit Labs Srl
| 510(k) | Device | Decision |
|---|---|---|
| K791097 | Ceptortrode with Ceptor HesiveGXY · Traditional | 08/03/1979SE |
| K791098 | Single-Use Mini-BulldogDXC · Traditional | 06/22/1979SE |
| K790763 | Maxi-Vac TMGCY · Traditional | 04/23/1979SE |
| K782006 | Medgeneral Single-Use BulldogGDJ · Traditional | 12/15/1978SE |
| K781239 | Myo-StimIPF · Traditional | 11/03/1978SE |
| K780632 | MaxiceptorISB · Traditional | 08/14/1978SE |
| K780698 | Stimulators, Nerve, ElectricalGZJ · Traditional | 05/12/1978SE |
| K780117 | CardiometerDRT · Traditional | 02/03/1978SE |
| K771702 | Vessel-StabilizerKDC · Traditional | 12/13/1977SE |
| K771701 | Vessel-CludeGDJ · Traditional | 12/13/1977SE |
Questions and answers
When was Ceptor Hesive cleared by the FDA?
Ceptor Hesive (K790269) received a 510(k) decision of Substantially Equivalent on February 26, 1979, 21 days after the submission was received.
What is the product code of K790269?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.