Dukal SMS Sterilization Wrap
FDA 510(k) clearance K233262 · decided 2024-03-22
Clearance details
- K-number
- K233262
- Device name
- Dukal SMS Sterilization Wrap
- Applicant
- Dukal, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2024-03-22
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ronkonkoma, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dukal
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.