510(k) K153258
K153258 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings (Dba Medline Renewal for the device "Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars". The FDA issued a decision of Substantially Equivalent on April 5, 2016. The device falls under product code NLM (Laparoscope, General & Plastic Surgery, Reprocessed), a Class II device regulated under 21 CFR 876.1500. Surgical Instrument Service and Savings (Dba Medline Renewal has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2016
- Date Received
- November 10, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, General & Plastic Surgery, Reprocessed
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
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 https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).