510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063245Substantially Equivalent

Elutia Coated Closed Surgical Wound Drain

Xtant Medical Holdings, Inc., Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063245 is the FDA 510(k) clearance record for ELUTIA COATED CLOSED SURGICAL WOUND DRAIN, a class II device, cleared for Bacterin International, Inc. on under FDA product code OEI (Drainage Catheter With Antibiotic). FDA's definition for product code OEI reads: "A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump". FDA records list 40 510(k) clearances for Xtant Medical Holdings, Inc., from to . As of , FDA records show 2 recalls naming K063245.

Clearance record

Decision date
Received
(398 days to decision)
Product code
OEI Drainage Catheter With Antibiotic
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bacterin International, Inc. 543 Long Hill Ave., Shelton CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEI

Trailing 12 months

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

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