Chrysalis Intelligence · Sponsors · Neotract, Inc.

Neotract, Inc.

Pleasanton, CA, US · 5 510(k) clearances · 1 recalls

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Total clearances

5

2020-04-14 → 2023-09-22

Last 12 months

0

Product codes

2

Most recent

2023-09-22

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
PEW	Implantable Transprostatic Tissue Retractor System	Class II	Gastroenterology, Urology	3	2023-09-22
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	Class II	General Hospital	2	2021-10-22

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2022-06-24

Date	Severity	Status	Recall #	Product	Code	Reason
2022-06-24	Class II	Ongoing	Z-1502-2022	UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool	—	There is the potential that during implant deployment, the device may not properly deliver a implant.

Filings

All 510(k) clearances (5)

Date	K-number	Device	Code	Class	Specialty
2023-09-22	K232558	UroLift 2 ATC Advanced Tissue Control System	PEW	Class II	Gastroenterology, Urology
2021-10-22	K212396	UroLift System Rigid Retrieval Kit Sterilization Tray	KCT	Class II	General Hospital
2020-07-31	K201837	UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge	PEW	Class II	Gastroenterology, Urology
2020-06-05	K200441	UroLift Advanced Tissue Control (ATC) System	PEW	Class II	Gastroenterology, Urology
2020-04-14	K192781	UroLift System Procedure Kit Sterilization Tray	KCT	Class II	General Hospital