510(k) K182828
K182828 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings, Inc. for the device "Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer". The FDA issued a decision of Substantially Equivalent on April 15, 2019. 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, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2019
- Date Received
- October 5, 2018
- 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).