Reprocessed Hand Activate Sealer/Divider
FDA 510(k) K111600 · Ascent Healthcare Solutions
510(k) numberK111600
Submission
- Device name
- Reprocessed Hand Activate Sealer/Divider
- Applicant
- Ascent Healthcare Solutions
Phoenix, AZ, US - Received
- June 8, 2011
- Decision date
- November 15, 2011
- 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).
Other 510(k)s with product code NUJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K110189 | Reprocessed Electrosurgical InstrumentNUJ · Traditional | 07/18/2011SE |
| K100909 | Reprocessed Compression SleevesJOW · Traditional | 07/23/2010SE |
| K100254 | Reprocessed CS Bi-Diectional Diagnostic Electrophysiology CatheterNLH · Traditional | 05/28/2010SE |
| K100537 | Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9…NLQ · Traditional | 05/12/2010SE |
| K100080 | Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional | 03/19/2010SE |
| K093702 | Reprocessed Ultrasonic Coagulating ShearsNLQ · Traditional | 03/04/2010SE |
| K092425 | Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10OWQ · Traditional | 10/21/2009SE |
| K090323 | Reprocessed Electrophysiology CathetersNLH · Traditional | 04/01/2009SE |
| K082023 | Reprocessed Electrophysiology CathetersNLH · Traditional | 09/16/2008SE |
| K081238 | Reprocessed Masimo Pulse Oximeter SensorsNLF · Traditional | 07/29/2008SE |
Questions and answers
When was Reprocessed Hand Activate Sealer/Divider cleared by the FDA?
Reprocessed Hand Activate Sealer/Divider (K111600) received a 510(k) decision of Substantially Equivalent on November 15, 2011, 160 days after the submission was received.
What is the product code of K111600?
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.