Device class
Class II
Regulation 876.1500
Total clearances
3
2021-10-14 → 2024-01-16
Definition
What is Laparoscopic Single Port Access Device
A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1500
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Dalim Medical Corp. |
1 |
0 |
2024-01-16 |
|
Afs Medical Co. , Ltd. |
1 |
0 |
2021-10-14 |
|
Incore Co., Ltd.
|
1 |
0 |
2022-09-28 |
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 |
| 49320 |
CPT
|
— |
Medium
|
Laparoscopy/laparoscopic procedure, surgical (general); single-port laparoscopic access device |
| 50545 |
CPT
|
— |
Medium
|
Laparoscopic nephrectomy; representative laparoscopic surgical code for single-port access |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-01-16 |
K232062 |
Dalim Medical Corp.
|
Uni-port |
| 2022-09-28 |
K220081 |
Incore Co., Ltd.
|
CORE-SPORT |
| 2021-10-14 |
K202688 |
Afs Medical Co. , Ltd.
|
AFS Medical Sterile Single-Use Access Port System |