| Device Type ID | 2617 |
| Device Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Regulation Description | Sterilization Wrap. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KCT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 2617 |
| Device | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Product Code | KCT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sterilization Wrap. |
| CFR Regulation Number | 880.6850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED STERILIZATION PRODUCTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ANTHOGYR | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAHADIR USA CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAHADIR USA LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDINAL HEALTH 200, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONMED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CONMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FLEXTRONICS INTERNATIONAL USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOLOGIC, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOLOGIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTITUT STRAUMANN AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTUITIVE SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICROLINE SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NOBEL BIOCARE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NOBEL BIOCARE AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSUNG MND CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARAGON MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PMBS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SCICAN LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOADCO, S.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERILUCENT, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
STRAUMANN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUMMIT MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
SYBRON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYMMETRY SURGICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THINK SURGICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILLIAM DEMANT HOLDING A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Integrity Problem | 12 |
Crack | 11 |
Device Operates Differently Than Expected | 8 |
Defective Device | 2 |
Device Damaged Prior To Use | 2 |
Material Fragmentation | 2 |
Hole In Material | 2 |
Material Separation | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Moisture Or Humidity Problem | 1 |
Loose Or Intermittent Connection | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Material Perforation | 1 |
Device Reprocessing Problem | 1 |
Material Disintegration | 1 |
Delivered As Unsterile Product | 1 |
Contamination / Decontamination Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Material Puncture / Hole | 1 |
| Total Device Problems | 53 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Aesculap Implant Systems LLC | II | Feb-15-2018 |
| 2 | Innovative Sterlization Technologies LLC | II | Oct-22-2015 |
| 3 | Integra York PA, Inc | II | Sep-11-2014 |
| 4 | PMBS, LLC | II | Mar-25-2016 |
| 5 | Symmetry Medical/SSI | II | Jan-27-2014 |
| 6 | Symmetry Surgical, Inc. | II | Jan-11-2017 |