Sterilization Pouch/Roll
FDA 510(k) clearance K251347 · decided 2026-01-28
Clearance details
- K-number
- K251347
- Device name
- Sterilization Pouch/Roll
- Applicant
- Sterivic Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-30
- Decision date
- 2026-01-28
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Chizhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.