510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OXTClass II

Percutaneous Surgical Set With Attachments

21 CFR 878.4805 / General, Plastic Surgery
FDA source (opens on fda.gov)

OXT is the FDA product code for Percutaneous Surgical Set With Attachments, a class II device type, regulated under 21 CFR 878.4805. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OXT
Device name
Percutaneous Surgical Set With Attachments
FDA 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.
Regulation
21 CFR 878.4805
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OXT

By decision year
1 clearance under product code OXT with a decision year between 2012 and 2012, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OXT by decision year
YearClearances
20121

Applicants with the most clearances

Product code OXT
Applicants holding the most 510(k) clearances under product code OXT
ApplicantClearances
Ethicon Endo-Surgery Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code