FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCU-BEAM WAVEGUIDE
K Number: K895656
·
Decision Feb 22, 1990
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
156
Basic Information
- Device Name
- ACCU-BEAM WAVEGUIDE
- K Number
- K895656
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- TTI MEDICAL
- Date Received
- September 19, 1989
- Decision Date
- February 22, 1990
- 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 |
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Other Clearances by TTI MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K952006 | ACCU-BEAM FIBER OPTIC HANDPIECE | May 31, 1995 | Substantially Equivalent |
| K951895 | ACCU-BEAM 300W XENON LIGHT SOURCE | May 24, 1995 | Substantially Equivalent |
| K945648 | ACCU-BEAM C02 LASER HANDPIECE | Feb 24, 1995 | Substantially Equivalent |
| K921208 | ACCU-BEAM TUBE SET | Jun 1, 1993 | Substantially Equivalent |
| K910978 | ACCU-BEAM LAPAROSCOPIC SYSTEM | Nov 7, 1991 | Substantially Equivalent |
| K890922 | ACCU-BEAM YAG FIBER | May 15, 1989 | Substantially Equivalent |
| K870063 | CO2 LASER BRONCHOSCOPE SET | Mar 9, 1987 | Substantially Equivalent |
| K870046 | DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET | Mar 5, 1987 | Substantially Equivalent |