FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUAL SYRINGE HOLDER
K Number: K082110
·
Decision Jun 17, 2009
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
88
Applicant Total
23
Review Days
324
Basic Information
- Device Name
- DUAL SYRINGE HOLDER
- K Number
- K082110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SURGIN SURGICAL INSTRUMENTATION, INC.
- Date Received
- July 28, 2008
- Decision Date
- June 17, 2009
- Product Code
- FMG
- 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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMG), ordered by most recent decision date.
Qitexio® 4-Way Stopcock (QIT014)
FDA 510(k)
FDA Class 2
·General Hospital
Three Way Stop Cock
FDA 510(k)
FDA Class 2
·General Hospital
lntravascular Administration Sets with Stopcock and Manifold
FDA 510(k)
FDA Class 2
·General Hospital
SafePort(TM) Manifold (or Stopcock)
FDA 510(k)
FDA Class 2
·General Hospital
Clicky Cross
FDA 510(k)
FDA Class 2
·General Hospital
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by SURGIN SURGICAL INSTRUMENTATION, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 | Mar 26, 2004 | Substantially Equivalent |
| K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | Jan 30, 2004 | Substantially Equivalent |
| K011195 | PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB | Nov 6, 2001 | Substantially Equivalent |
| K994015 | ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 | Mar 15, 2000 | Substantially Equivalent |
| K980849 | SURGIN KIT | Jul 9, 1998 | Substantially Equivalent |
| K954238 | SURGIN GENISIS HANDPIECE | Dec 8, 1995 | Substantially Equivalent |
| K950600 | VACUUM SURGE SUPRESSER | May 10, 1995 | Substantially Equivalent |
| K942945 | CASSETTE SYSTEM FOR STORZ | Dec 5, 1994 | Substantially Equivalent |
| K942944 | IRRIGATION/BIPOLAR SET | Sep 27, 1994 | Substantially Equivalent |
| K942897 | OPTHALMIC WIPE | Aug 5, 1994 | Substantially Equivalent |