REPROCESSED CLOSURE SYSTEM
FDA 510(k) clearance K133414 · decided 2014-01-22
Clearance details
- K-number
- K133414
- Device name
- REPROCESSED CLOSURE SYSTEM
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-07
- Decision date
- 2014-01-22
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- NLM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sterilmed
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
| Record | Firm | Date |
|---|---|---|
| Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic a recall (Z-1630-2015) | CooperSurgical, Inc. | 2015-05-19 |