Product code LLW— Obstetrics/Gynecology
DISPOSABLE LARYNGOSCOPE
- Classification name
- Laser, Neodymium:Yag For Gynecologic Use
- Device class
- Class 2
- Regulation
- 21 CFR 884.4550
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LLW
FDA has cleared device under product code LLW, all in 1985, 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 LLW
Recent clearances under product code LLW
Data sourced from openFDA. This site is unofficial and independent of the FDA.