FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Unistik® ShieldLock, Unistik VacuFlip
K Number: K223854
·
Decision Jun 30, 2023
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
13
Review Days
189
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Basic Information
- Device Name
- Unistik® ShieldLock, Unistik VacuFlip
- K Number
- K223854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Owen Mumford, Ltd.
- Date Received
- December 23, 2022
- Decision Date
- June 30, 2023
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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Other Clearances by Owen Mumford, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231124 | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) | Jun 27, 2023 | Substantially Equivalent |
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| K222303 | Unistik® Pro | Oct 25, 2022 | Substantially Equivalent |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | Oct 3, 2022 | Substantially Equivalent |
| K222111 | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G | Sep 7, 2022 | Substantially Equivalent |
| K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | Aug 12, 2022 | Substantially Equivalent |
| K210399 | Unifine SafeControl | Sep 17, 2021 | Substantially Equivalent |
| K173881 | Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G | Jul 11, 2018 | Substantially Equivalent |
| K152339 | Unifine Pentips/ Unifine Pentips Plus | Jun 24, 2016 | Substantially Equivalent |
| K122837 | AUTOJECT 2 FOR GLASSY SYRINGE | Oct 15, 2012 | Substantially Equivalent |