FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
10CC CONTROL SYRINGE
K Number: K873588
·
Decision Oct 23, 1987
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
12
Review Days
49
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
- 10CC CONTROL SYRINGE
- K Number
- K873588
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medi-Plast Intl., Inc.
- Date Received
- September 4, 1987
- Decision Date
- October 23, 1987
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMF), ordered by most recent decision date.
Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
FDA 510(k)
FDA Class 2
·General Hospital
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
FDA 510(k)
FDA Class 2
·General Hospital
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Instylla Delivery Kit
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Medi-Plast Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954284 | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) | Feb 12, 1996 | Substantially Equivalent |
| K863402 | MEDI-PLAST DISPOSABLE MANIFOLD | Oct 22, 1986 | Substantially Equivalent |
| K861785 | FLUOROSCOPE BAND BAG | Jun 13, 1986 | Substantially Equivalent |
| K851489 | ARTERIAL-VENOUS COMPRESSION DRESSING | Jun 11, 1985 | Substantially Equivalent |
| K842136 | STERILE PAN SET | Jul 6, 1984 | Substantially Equivalent |
| K840021 | OPERATING ROOM TRAY SET | Mar 15, 1984 | Substantially Equivalent |
| K840022 | HEART CATHETERIZATION TRAY SET | Feb 4, 1984 | Substantially Equivalent |
| K811268 | BOTTLE-TO-BOTTLE | Jun 18, 1981 | Substantially Equivalent |
| K811234 | I.V. BOTTLE (RIDGID) | Jun 18, 1981 | Substantially Equivalent |
| K811233 | I.V. PLASTIC BAG | Jun 17, 1981 | Substantially Equivalent |