510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122263Substantially Equivalent

14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use

Symmetry Medical, Antioch TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122263 is the FDA 510(k) clearance record for 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE, a class II device, cleared for Symmetry Medical on under FDA product code ODY (Tunneled Catheter Remover). FDA's definition for product code ODY 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...". FDA records list 3 510(k) clearances for Symmetry Medical, from to . As of , FDA records show no recalls naming K122263.

Clearance record

Decision date
Received
(63 days to decision)
Product code
ODY Tunneled Catheter Remover
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
Symmetry Medical 3034 Owen Dr., Antioch TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODY

Trailing 12 months

FDA records hold no clearances under product code ODY in the trailing twelve months.

FDA records show no clearances under product code ODY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260