FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tamper Evident Cap
K Number: K193192
·
Decision Jan 31, 2020
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
7
Review Days
73
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Basic Information
- Device Name
- Tamper Evident Cap
- K Number
- K193192
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Medical Industries, Inc.
- Date Received
- November 19, 2019
- Decision Date
- January 31, 2020
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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Other Clearances by International Medical Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231095 | Tamper Evident Cap | Sep 4, 2024 | Substantially Equivalent |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | Dec 16, 2020 | Substantially Equivalent |
| K190305 | Additive Cap | Apr 30, 2019 | Substantially Equivalent |
| K182545 | Tamper Evident Cap with Male Luer Lock | Jan 11, 2019 | Substantially Equivalent |
| K173577 | Guarded Luer Connector | Jun 7, 2018 | Substantially Equivalent |
| K170672 | Tamper Evident Cap For use with ENFit Syringes | Oct 6, 2017 | Substantially Equivalent |