FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCU-BEAM 300W XENON LIGHT SOURCE
K Number: K951895
·
Decision May 24, 1995
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
46
Applicant Total
9
Review Days
30
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Basic Information
- Device Name
- ACCU-BEAM 300W XENON LIGHT SOURCE
- K Number
- K951895
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tti Medical
- Date Received
- April 24, 1995
- Decision Date
- May 24, 1995
- Product Code
- GCT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| GCT | Light Source, Endoscope, Xenon Arc | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Tti Medical
| K Number | Device Name | ||
|---|---|---|---|
| K952006 | ACCU-BEAM FIBER OPTIC HANDPIECE | May 31, 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 |
| K895656 | ACCU-BEAM WAVEGUIDE | Feb 22, 1990 | 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 |