Product code HGK— Obstetrics/Gynecology
KSEA SCALP BLOOD COLLECTION SET
- Classification name
- Endoscope, Fetal Blood Sampling (And Accessories)
- Device class
- Class 2
- Regulation
- 21 CFR 884.1660
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code HGK
FDA has cleared device under product code HGK, all in 1996, 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 HGK
Recent clearances under product code HGK
Data sourced from openFDA. This site is unofficial and independent of the FDA.