PSI FLEXIBLE ARM
FDA 510(k) clearance K942601 · decided 1994-12-27
Clearance details
- K-number
- K942601
- Device name
- PSI FLEXIBLE ARM
- Applicant
- V. Mueller Neuro/Spine
- Decision
- Substantially Equivalent
- Date received
- 1994-06-01
- Decision date
- 1994-12-27
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch V. Mueller Neuro/Spine
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.