American Optisurgical, Inc.
American Optisurgical, Inc. holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2010, with 4 FDA device recalls on record.
Top product codes for American Optisurgical, Inc.
FDA recalls by American Optisurgical, Inc.
- Z-1505-2013 — FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
- Z-1518-2013 — TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
- Z-1516-2013 — American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
- Z-1817-2012 — TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by American Optisurgical, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.