FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GS-2100 HOOK SUTURE SCISSOR, 5MM
K Number: K900957
·
Decision Apr 18, 1990
Classifications
1
FEI Numbers
509
Registration Numbers
509
Same Product Code
17
Applicant Total
21
Review Days
50
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
- GS-2100 HOOK SUTURE SCISSOR, 5MM
- K Number
- K900957
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Solos Endoscopy, Inc.
- Date Received
- February 27, 1990
- Decision Date
- April 18, 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
SUTURE REMOVAL TRAY
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 Solos Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983538 | MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY | Nov 6, 1998 | Substantially Equivalent |
| K910671 | MODEL GS-4700 COMMON DUCT STONE REMOVING KIT | May 10, 1991 | Substantially Equivalent |
| K900964 | CANNULA AND TROCAR, 11MM | Apr 18, 1990 | Substantially Equivalent |
| K900959 | GS-1400 TOOTHED DISSECTING FORCEP, 5MM, INSULATED | Apr 18, 1990 | Substantially Equivalent |
| K900965 | GS-4550 TROCAR ONLY, 11MM | Apr 18, 1990 | Substantially Equivalent |
| K900954 | GS-5200 HOOK SUCTION/COAGULATOR, 5MM | Apr 18, 1990 | Substantially Equivalent |
| K900961 | GS-4100 REDUCER SLEEVE, 5MM TO 3MM | Apr 18, 1990 | Substantially Equivalent |
| K900948 | GS-1002 GRASPING FORCEP, 5MM WITH RATCHET | Apr 18, 1990 | Substantially Equivalent |
| K900953 | GS-5000 SPATULA SUCTION/COAGULATOR, 5MM | Apr 18, 1990 | Substantially Equivalent |
| K900952 | GS-1200 GRASPING/EXTRACTING FORCEP, 10MM | Apr 18, 1990 | Substantially Equivalent |