FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
K Number: K933319
·
Decision Oct 27, 1993
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
13
Review Days
112
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Basic Information
- Device Name
- BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
- K Number
- K933319
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Birtcher Medical Systems, Inc.
- Date Received
- July 7, 1993
- Decision Date
- October 27, 1993
- Product Code
- GCY
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Birtcher Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932779 | BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS. | Mar 21, 1995 | Substantially Equivalent |
| K944681 | LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES | Dec 22, 1994 | Substantially Equivalent |
| K930887 | BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600) | Apr 25, 1994 | Substantially Equivalent |
| K931771 | BIRTCHER ENDOSCOPIC CORKSCREW | Apr 25, 1994 | Substantially Equivalent |
| K931654 | BIRTCHER MAGNETIC RETRIEVER (GS-3100) | Apr 25, 1994 | Substantially Equivalent |
| K932987 | BIRTCHER LAPAROSCOPE AND ACCESSORIES | Apr 25, 1994 | Substantially Equivalent |
| K936114 | BIRTCHER PERICARDIAL KNIVES | Apr 25, 1994 | Substantially Equivalent |
| K930302 | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | Oct 27, 1993 | Substantially Equivalent |
| K930496 | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS | Apr 20, 1993 | Substantially Equivalent |
| K925824 | SOLOS FAN RETRACTORS | Mar 1, 1993 | Substantially Equivalent |