Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
FDA 510(k) clearance K182828 · decided 2019-04-15
Clearance details
- K-number
- K182828
- Device name
- Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-10-05
- Decision date
- 2019-04-15
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- NLM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Surgical Instrument Service and Savings
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.