ELUTIA COATED CLOSED SURGICAL WOUND DRAIN— 510(k) K063245
Substantially EquivalentBacterin International, Inc.
FDA 510(k) clearance K063245 for ELUTIA COATED CLOSED SURGICAL WOUND DRAIN, Substantially Equivalent on 2007-11-28. Applicant: Bacterin International, Inc.. Device class: 2.
Clearance details
- Applicant
- Bacterin International, Inc.
- Product code
- Code OEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
More clearances from Bacterin International, Inc.
view allRecalls naming K063245
K-number listed on FDA's recall record- Z-1680-2014 — Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
- Z-0936-2013 — Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063245.
Data sourced from openFDA. This site is unofficial and independent of the FDA.