Electrode, Dispersive, Disp. Neopad
FDA 510(k) K780118 · Neomed Corp.
510(k) numberK780118
Submission
- Device name
- Electrode, Dispersive, Disp. Neopad
- Applicant
- Neomed Corp.
Mchenry, IL, US - Received
- January 23, 1978
- Decision date
- February 23, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HAM – Apparatus, Electrosurgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K153472 | Quiver Laparoscopic ExtendableHAM · Traditional | Itl Corporation Pty, Ltd. | 06/23/2016SE |
| K000079 | Nikopad Electrosurgical Grounding Pad, Model 4777MHAM · Special | Nikomed U.S.A., Inc. | 02/04/2000SE |
| K993306 | Nikopad Electrosurgical Grounding Pad (*Or Sold Under Commercial Names), Model 4760…HAM · Special | Paladin Medical, Inc. | 11/03/1999SE |
| K945861 | Bergen 710 EsuHAM · Traditional | Bergen Mfg. | 03/01/1995SE |
| K913300 | Laparostat(Tm)HAM · Traditional | Cook Ob/Gyn | 04/02/1992SE |
| K920100 | Gsu Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 02/03/1992SE |
| K911353 | Emc Model No. Statome 900HAM · Traditional | Emc Industries | 06/24/1991SE |
| K901248 | Abc Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 04/03/1990SE |
| K881334 | Light Coagulator LC 250HAM · Traditional | Nk-Optik GmbH | 11/16/1989SE |
| K895337 | Electrosurgical Coagulation Suction TubeHAM · Traditional | New England Surgical Instrument Corp. | 09/15/1989SE |
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| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…PNR · Traditional | 06/17/2016SE |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsPNR · Traditional | 12/17/2015SE |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit ConnectorPNR · Traditional | 04/09/2015SE |
| K122373 | Neomed Oral/Enteral SyringeFMF · Special | 09/20/2012SE |
| K120182 | Neomed Gastrointestinal Tube and AccessoriesKNT · Traditional | 04/19/2012SE |
| K100288 | Neomed Enteral Only Extension SetKNT · Traditional | 08/03/2010SE |
| K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO…FMF · Traditional | 03/10/2010SE |
| K082238 | Neomed Polyurethane Feeding TubeFPD · Special | 10/01/2008SE |
| K081515 | Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0FOS · Special | 07/21/2008SE |
Questions and answers
When was Electrode, Dispersive, Disp. Neopad cleared by the FDA?
Electrode, Dispersive, Disp. Neopad (K780118) received a 510(k) decision of Substantially Equivalent on February 23, 1978, 31 days after the submission was received.
What is the product code of K780118?
The FDA product code is HAM – Apparatus, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.