Reprocessed ArthroCare ENT Coblator
FDA 510(k) K172647 · Renovo, Inc.
510(k) numberK172647
Submission
- Device name
- Reprocessed ArthroCare ENT Coblator
- Applicant
- Renovo, Inc.
Bend, OR, US - Received
- September 1, 2017
- Decision date
- February 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUJ – Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)NUJ · Traditional | Surgical Instrument Service and Savings, Inc. | 04/29/2024SE |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Special | Stryker Sustainability Solutions | 03/28/2023SE |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Traditional | Stryker Sustainability Solutions | 05/13/2022SE |
| K211203 | Green OR Reprocessed Aquamantys Bipolar SealerNUJ · Traditional | Green Or, LLC | 04/07/2022SE |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterNUJ · Traditional | Vein 360, LLC | 10/22/2019SE |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 10/31/2018SE |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ · Traditional | Stryker Sustainability Solutions | 04/23/2018SE |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/DividerNUJ · Traditional | Stryker Sustainability Solutions | 04/20/2018SE |
| K173214 | NES Reprocessed RF Stylet (RFS)NUJ · Traditional | Northeast Scientific, Inc. (Nes) | 03/27/2018SE |
| K173740 | Reprocessed DePuy Mitek Ablation WandNUJ · Traditional | Renovo, Inc. | 03/19/2018SE |
More from Renovo, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173740 | Reprocessed DePuy Mitek Ablation WandNUJ · Traditional | 03/19/2018SE |
| K173741 | Reprocessed ArthoCare Ablation WandNUJ · Traditional | 03/05/2018SE |
| K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesNLM · Traditional | 10/06/2017SE |
| K172093 | Reprocessed Covidien TrocarNLM · Traditional | 10/05/2017SE |
| K172092 | Reprocessed Shavers/BursHRX · Traditional | 10/04/2017SE |
Questions and answers
When was Reprocessed ArthroCare ENT Coblator cleared by the FDA?
Reprocessed ArthroCare ENT Coblator (K172647) received a 510(k) decision of Substantially Equivalent on February 21, 2018, 173 days after the submission was received.
What is the product code of K172647?
The FDA product code is NUJ – Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 878.4400.