FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASER LAPAROSCOPY SET
K Number: K873598
·
Decision Jan 20, 1988
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
17
Review Days
138
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Basic Information
- Device Name
- LASER LAPAROSCOPY SET
- K Number
- K873598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Cuda Products Co.
- Date Received
- September 4, 1987
- Decision Date
- January 20, 1988
- Product Code
- HET
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Cuda Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | Dec 16, 1998 | Substantially Equivalent |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Aug 18, 1998 | Substantially Equivalent |
| K981469 | CERMAX300 LIGHTSOURCE | Jul 9, 1998 | Substantially Equivalent |
| K980350 | VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 | Apr 28, 1998 | Substantially Equivalent |
| K980166 | LIGHTSOURCE OR ILLUMINATOR | Apr 1, 1998 | Substantially Equivalent |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | Apr 30, 1996 | Substantially Equivalent |
| K951019 | INTRAORAL VIDEO SCOPE AND WINDOW TUBE | May 10, 1995 | Substantially Equivalent |
| K943731 | VIDEO OTOSCOPE | Oct 11, 1994 | Substantially Equivalent |
| K935818 | ENDOSCOPE | Jul 13, 1994 | Substantially Equivalent |
| K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES | Jan 3, 1994 | Substantially Equivalent |