Chrysalis Intelligence · Product Codes · PEW

PEW · Implantable Transprostatic Tissue Retractor System

Gastroenterology, Urology · 3 clearances · 1 unique sponsors

Device class
Class II
Regulation 876.5530
Total clearances
3
2020-06-05 → 2023-09-22
Last 12 months
0
Unique sponsors
1
Definition

What is Implantable Transprostatic Tissue Retractor System

The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5530
Implant
Y
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
Neotract, Inc. 3 0 2023-09-22
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
52441 CPT High Transurethral incision/resection of prostate; standard BPH treatment code
52442 CPT Medium Transurethral resection of prostate, >45g; alternative BPH procedure code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2023-09-22 K232558 Neotract, Inc. UroLift 2 ATC Advanced Tissue Control System
2020-07-31 K201837 Neotract, Inc. UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
2020-06-05 K200441 Neotract, Inc. UroLift Advanced Tissue Control (ATC) System