Duns Number:303655286
Device Description: FiXcision is an EO‐sterilized, single use, multi‐part, manual cutting instrument for use d FiXcision is an EO‐sterilized, single use, multi‐part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae.
Catalog Number
FIX2001
Brand Name
FiXcision
Version/Model Number
FIX2001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182664,K182664
Product Code
KOA
Product Code Name
Surgical Instruments, G-U, Manual (And Accessories)
Public Device Record Key
8c09fdfc-9e6d-4255-ab1d-e5072a4d1faa
Public Version Date
April 12, 2019
Public Version Number
2
DI Record Publish Date
December 14, 2018
Package DI Number
EAMIFIX20011
Quantity per Package
10
Contains DI Package
EAMIFIX20010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |