Product code LBX— Obstetrics/Gynecology
OP-CON SURGICAL INSTRUMENTS #4
- Classification name
- Pelvimeter, Internal
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LBX
FDA has cleared device under product code LBX, all in 1983, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code LBX
Recent clearances under product code LBX
Data sourced from openFDA. This site is unofficial and independent of the FDA.