FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDIGROUP LS-110 LIGHT SOURCE
K Number: K823294
·
Decision May 9, 1983
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
336
Applicant Total
9
Review Days
185
Basic Information
- Device Name
- MEDIGROUP LS-110 LIGHT SOURCE
- K Number
- K823294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- MEDIGROUP
- Date Received
- November 5, 1982
- Decision Date
- May 9, 1983
- 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 MEDIGROUP
| K Number | Device Name | ||
|---|---|---|---|
| K823297 | ST-610 NEEDLESCOPE STERILIZATION TRAY | May 6, 1983 | Substantially Equivalent |
| K823295 | MEDIGROUP 2.2MM NEEDLESCOPE CANNULA& | May 6, 1983 | Substantially Equivalent |
| K823293 | MEDIGROUP LG-102 LIGHT GUIDE | May 5, 1983 | Substantially Equivalent |
| K823390 | PC 201A LOCKING SLEEVE | Jan 26, 1983 | Substantially Equivalent |
| K823331 | PC-204 TUNNELOR | Jan 26, 1983 | Substantially Equivalent |
| K823296 | PC-205 TENCKHOFF CATHETER ROD OBTURATOR | Jan 26, 1983 | Substantially Equivalent |
| K823330 | DIALATORS PC-203 & 202 | Jan 26, 1983 | Substantially Equivalent |
| K823303 | QUILL CATHETER GUIDE | Jan 26, 1983 | Substantially Equivalent |