FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
BH Sterilization Pouch
K Number: K172280
·
Decision Aug 3, 2018
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
3
Review Days
371
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BH Sterilization Pouch
- K Number
- K172280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bh Medical Products Co., Ltd.
- Date Received
- July 28, 2017
- Decision Date
- August 3, 2018
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRG), ordered by most recent decision date.
Dukal Crepe Paper Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
Sterilization Pouch/Roll
FDA 510(k)
FDA Class 2
·General Hospital
Self-Seal Sterilization Pouch and Roll
FDA 510(k)
FDA Class 2
·General Hospital
Chex-All Sterilization Pouches and Tubes
FDA 510(k)
FDA Class 2
·General Hospital
Sterilization Pouch and Roll
FDA 510(k)
FDA Class 2
·General Hospital