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

Tunneled Catheter Remover

21 CFR 880.5970 / General Hospital
FDA source (opens on fda.gov)

ODY is the FDA product code for Tunneled Catheter Remover, a class II device type, regulated under 21 CFR 880.5970. FDA's definition for this code reads: "To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
ODY
Device name
Tunneled Catheter Remover
FDA definition
To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code ODY

By decision year
2 clearances under product code ODY with a decision year between 2007 and 2012, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ODY by decision year
YearClearances
20071
20121

Applicants with the most clearances

Product code ODY
Applicants holding the most 510(k) clearances under product code ODY
ApplicantClearances
Symmetry Medical1
Tran Pa-C, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code