Chrysalis Intelligence · Product Codes · QYZ

QYZ · At Home Intravaginal Insemination System

Obstetrics/Gynecology · 3 clearances · 3 unique sponsors

Device class
Class II
Regulation 884.6110
Total clearances
3
2023-11-29 → 2023-12-21
Last 12 months
0
Unique sponsors
3
Definition

What is At Home Intravaginal Insemination System

To deliver semen to the vaginal canal for insemination.
Medical specialty
Obstetrics/Gynecology
Review panel
OB
Regulation number
884.6110
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Hannah Life Technologies Pte , Ltd. 1 0 2023-12-21
Mosie Baby 1 0 2023-11-29
Pherdal Fertility Science, Inc. 1 0 2023-12-14
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
58970 CPT Medium Follicle puncture for oocyte retrieval, related to fertility procedures using insemination devices
58974 CPT Medium Embryo transfer; intravaginal insemination delivery system used in ART
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2023-12-21 K232579 Hannah Life Technologies Pte , Ltd. Twoplus Applicator
2023-12-14 K231645 Pherdal Fertility Science, Inc. PherDal® At-Home Insemination Kit
2023-11-29 K231203 Mosie Baby Mosie Baby Kit