Device class
Class II
Regulation 884.6100
Total clearances
3
2024-02-22 → 2026-06-15
Classification details
Medical specialty
Obstetrics/Gynecology
Regulation number
884.6100
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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.
| Code | Type | Description | Confidence | Rationale |
| A4286 |
HCPCS
|
Locking ring for breast pump, replacement ✓ CMS-verified description |
Medium
|
Needle, assisted reproduction, per needle |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-15 |
K253121 |
Gimbo Medical Technology Shenzhen Co., Ltd.
|
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle |
| 2024-11-15 |
K240523 |
Shenzhen Vitavitro Biotech Co., Ltd.
|
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) |
| 2024-02-22 |
K232163 |
Zhejiang Horizon Medical Technology Co., Ltd.
|
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle |