Tissue-containment system
LapBox Manual ↗
Tissue-containment removal system for manual morcellation. [5][1]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Companies / Ark Surgical
Medical device company profile
Ark Surgical
LapBox tissue-containment systems for manual and power morcellation during minimally invasive gynecologic surgery.
Medical Device ManufacturerWomen’s & Reproductive HealthGynecologic SurgeryCommercial-stage
Company overview
Ark Surgical develops tissue-containment technology for minimally invasive women’s health procedures. Its LapBox systems use a dual-wall containment design to support removal of tissue during laparoscopic hysterectomy and myomectomy workflows.
The company has separate FDA 510(k) clearances for the LapBox manual tissue-removal system and the LapBox Power Tissue Containment System. Power and manual configurations have distinct regulatory records, compatibility requirements and labeling; containment does not eliminate every clinical risk.
Stav Tori serves as CEO, with Joseph LaBruzzo leading U.S. operations. The company’s commercial work includes surgeon training, hospital adoption and expansion of its U.S. presence, supported by a team spanning device development and gynecologic clinical expertise.
Leadership
4 peopleStav ToriChief Executive Officer [5]
Joseph B. LaBruzzoBoard Member & President/CEO of U.S. Operations [5]
Abraham YaariCo-Founder & Chief Scientist [5]
Edward EvantashChief Medical Officer [5]
Products & regulatory status How does MedTechIndex get this information?
Summary
LapBox Manual and LapBox Power have separate FDA 510(k) decisions. Their containment-system clearances apply to the labeled configurations and patient-selection limits, rather than establishing that morcellation is appropriate for every patient. [5][3][4][6][7]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [9][10]
Regulatory snapshot How to read this snapshot
U.S. FDA- 2
- 510(k) clearances
- 0
- De Novo grants
- 0
- PMA approvals
- 0
- Recall events
Latest recorded source review: 2026-10-20.
Commercial portfolio snapshot
Documented commercial product families.
Tissue-containment system
LapBox Power ↗
Tissue-containment system for use with compatible power morcellators. [5][2]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial development
Commercial manual and power containment systems; each configuration requires its own labeling and clinical selection. [5]
Activity & Milestones
1 events2025-04-15 · Regulatory
LapBox Power FDA clearance
FDA issued a substantially equivalent decision for LapBox Power. [2]
13 Cited Sources
Accessed 10/29/2026
13 Cited Sources
Accessed 10/29/2026
[1] FDA 510(k) K221365 ↗U.S. Food and Drug Administration · regulatory database
[2] FDA 510(k) K250212 ↗U.S. Food and Drug Administration · regulatory database
[3] FDA K221365 — LapBox Tissue Containment Removal System ↗U.S. Food and Drug Administration · regulatory record
[4] FDA K250212 — LapBox Power Tissue Containment System ↗U.S. Food and Drug Administration · regulatory record
[5] Company, leadership and LapBox portfolio ↗Ark Surgical · company website
[6] Hiring source review ↗Ark Surgical · company website
[7] FDA 510(k) database — research search ↗FDA / openFDA · regulatory record
[8] FDA PMA database — research search ↗FDA / openFDA · regulatory record
[9] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[10] FDA medical-device recall database — research search ↗FDA / openFDA · regulatory record
[11] FDA UDI database — research search ↗FDA / openFDA · regulatory record
[12] FDA De Novo database — research search ↗FDA / openFDA · regulatory record
[13] Ark Surgical company release announcing US$2.1 million financing ↗Ark Surgical · company announcement