TROCAR (FALLER STYLET)
FDA 510(k) clearance K910786 · decided 1991-09-19
Clearance details
- K-number
- K910786
- Device name
- TROCAR (FALLER STYLET)
- Applicant
- Accurate Surgical Instruments Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-25
- Decision date
- 1991-09-19
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- FJS
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Toronto Canado M5v 1y9, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Accurate Surgical Instruments Co.
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.