FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
K Number: K872711
·
Decision Sep 28, 1987
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
39
Review Days
83
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
- MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
- K Number
- K872711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Directed Energy, Inc.
- Date Received
- July 7, 1987
- Decision Date
- September 28, 1987
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASEmaR 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNE PureHygiene
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Directed Energy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904930 | SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH | Mar 21, 1991 | Substantially Equivalent |
| K894241 | MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT | Jun 18, 1990 | Substantially Equivalent |
| K883738 | CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. | Nov 15, 1988 | Substantially Equivalent |
| K882926 | MODEL AU-1 ACCESSORY UNIT | Sep 9, 1988 | Substantially Equivalent |
| K880216 | MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. | Mar 4, 1988 | Substantially Equivalent |
| K873331 | ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG | Feb 17, 1988 | Substantially Equivalent |
| K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | Feb 2, 1988 | Substantially Equivalent |
| K872709 | MODEL 20-C, RL-20A/U, OB-10A/U | Feb 2, 1988 | Substantially Equivalent |
| K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | Sep 24, 1987 | Substantially Equivalent |
| K870840 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH | Jun 12, 1987 | Substantially Equivalent |