HYBRID TROCAR SYSTEM
FDA 510(k) clearance K101937 · decided 2010-08-11
Clearance details
- K-number
- K101937
- Device name
- HYBRID TROCAR SYSTEM
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-12
- Decision date
- 2010-08-11
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Aesculap
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.