FLASHPAK
FDA 510(k) clearance K113776 · decided 2012-08-08
Clearance details
- K-number
- K113776
- Device name
- FLASHPAK
- Applicant
- Symmetry Medical
- Decision
- Substantially Equivalent
- Date received
- 2011-12-22
- Decision date
- 2012-08-08
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- New Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, recall (Z-1010-2017) | Symmetry Surgical, Inc. | 2017-01-11 |
| symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-S recall (Z-1011-2017) | Symmetry Surgical, Inc. | 2017-01-11 |
| symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, recall (Z-1012-2017) | Symmetry Surgical, Inc. | 2017-01-11 |