7-510-25 HYSTEROMED TUBING KIT
FDA 510(k) clearance K931606 · decided 1994-01-24
Clearance details
- K-number
- K931606
- Device name
- 7-510-25 HYSTEROMED TUBING KIT
- Applicant
- Nortech
- Decision
- Substantially Equivalent
- Date received
- 1993-04-01
- Decision date
- 1994-01-24
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- HIG
- Device class
- 2
- Regulation number
- 884.1700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Arlington Heights, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nortech
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.