FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
SUTURE REMOVAL TRAY
K Number: K902828
·
Decision Aug 8, 1990
Classifications
1
FEI Numbers
509
Registration Numbers
509
Same Product Code
17
Applicant Total
33
Review Days
41
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
- SUTURE REMOVAL TRAY
- K Number
- K902828
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Orion Life Systems, Inc.
- Date Received
- June 28, 1990
- Decision Date
- August 8, 1990
- Product Code
- LRW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRW | Scissors, General, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRW), ordered by most recent decision date.
MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GS-2100 HOOK SUTURE SCISSOR, 5MM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PLASTER CUTTING SCISSORS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SCISSORS, VARIOUS TYPES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OLIVECORONA SCISSORS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Orion Life Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943835 | PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID | Jan 24, 1995 | Substantially Equivalent |
| K943834 | STERILE .9% SODIUM CHLORIDE SOLUTION | Nov 21, 1994 | Substantially Equivalent |
| K943830 | PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION | Nov 21, 1994 | Substantially Equivalent |
| K943836 | PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER | Nov 21, 1994 | Substantially Equivalent |
| K943831 | PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER | Nov 21, 1994 | Substantially Equivalent |
| K943832 | STERILE .9% SODIUM CHLORIDE FOR IRRATION | Nov 21, 1994 | Substantially Equivalent |
| K943829 | PRE-FILLED SYSRINGE W/STERILE WATER | Nov 21, 1994 | Substantially Equivalent |
| K943828 | STERILE WATER FOR IRRIGATION | Nov 21, 1994 | Substantially Equivalent |
| K943833 | STERILE WATER FOR IRRATION | Nov 1, 1994 | Substantially Equivalent |
| K923168 | DUAL PORT ENTERAL Y-ADAPTOR | Jun 17, 1994 | Substantially Equivalent |