Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
FDA 510(k) K182828 · Surgical Instrument Service and Savings, Inc.
510(k) numberK182828
Submission
- Device name
- Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
- Applicant
- Surgical Instrument Service and Savings, Inc.
Redmond, OR, US - Received
- October 5, 2018
- Decision date
- April 15, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLM – Laparoscope, General & Plastic Surgery, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at…
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| K201511 | Reprocessed Endoscopic Trocars and SleevesNLM · Traditional | Stryker Sustainability Solutions | 07/31/2020SE |
| K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesNLM · Traditional | Renovo, Inc. | 10/06/2017SE |
| K172093 | Reprocessed Covidien TrocarNLM · Traditional | Renovo, Inc. | 10/05/2017SE |
| K160740 | Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW TechnologyNLM · Traditional | Surgical Instrument Service and Savings, Inc. | 05/06/2016SE |
| K153258 | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical TrocarsNLM · Traditional | Surgical Instrument Service and Savings (Dba… | 04/05/2016SE |
| K133414 | Reprocessed Closure SystemNLM · Traditional | Sterilmed, Inc. | 01/22/2014SE |
| K132629 | Reprocessed Dilating Tip TrocarsNLM · Traditional | Stryker Sustainability Solutions | 12/31/2013SE |
| K121240 | Reprocessed Endoscopic TrocarsNLM · Traditional | Sterilmed, Inc. | 06/11/2012SE |
| K111002 | Reprocessed Endoscopic TrocarsNLM · Traditional | Sterilmed, Inc. | 07/18/2011SE |
| K100080 | Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional | Ascent Healthcare Solutions | 03/19/2010SE |
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Questions and answers
When was Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer cleared by the FDA?
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer (K182828) received a 510(k) decision of Substantially Equivalent on April 15, 2019, 192 days after the submission was received.
What is the product code of K182828?
The FDA product code is NLM – Laparoscope, General & Plastic Surgery, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 876.1500.