Product code OXT— General, Plastic Surgery

PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS

Classification name: Percutaneous Surgical Set With Attachments
Device class: Class 2
Regulation: 21 CFR 878.4805
Advisory panel: General, Plastic Surgery
Total cleared: 1
First cleared: 2012-04-30
Most recent: 2012-04-30

FDA classification definition

“Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues.”
— U.S. Food and Drug Administration, device classification record for product code OXT under 21 CFR 878.4805, via openFDA

Market context for product code OXT

FDA has cleared 1 device under product code OXT, all in 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OXT

Ethicon Endo-Surgery1 clearance

Recent clearances under product code OXT

DEN110016 — PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTSEthicon Endo-Surgery·2012-04-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.