510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN110016Unknown

Percutaneous Surgical Set with 5Mm or 10Mm Attachments

Ethicon Endo-Surgery Inc, Cincinnati OH / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN110016 is the FDA 510(k) clearance record for PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS, a class II device, cleared for Ethicon Endo-Surgery on under FDA product code OXT (Percutaneous Surgical Set With Attachments). FDA's definition for product code OXT 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...". FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, from to . As of , FDA records show no recalls naming DEN110016.

Clearance record

Decision date
Received
(222 days to decision)
Product code
OXT Percutaneous Surgical Set With Attachments
Regulation
21 CFR 878.4805
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ethicon Endo-Surgery 4545 Creek Rd., Cincinnati OH
Third party review
No

Clearances, product code OXT

Trailing 12 months

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

FDA records show no clearances under product code OXT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXT, 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