FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESPI REDUCER SLEEVE, #8415
K Number: K903596
·
Decision Sep 12, 1990
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
12
Review Days
35
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Basic Information
- Device Name
- ESPI REDUCER SLEEVE, #8415
- K Number
- K903596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Dixon Medical, Inc.
- Date Received
- August 8, 1990
- Decision Date
- September 12, 1990
- 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 Dixon Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903599 | ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N | Oct 17, 1990 | Substantially Equivalent |
| K903598 | ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N | Oct 17, 1990 | Substantially Equivalent |
| K903600 | ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N | Oct 17, 1990 | Substantially Equivalent |
| K903593 | ESPI APPLICATOR SLEEVE, #8410 | Sep 12, 1990 | Substantially Equivalent |
| K903597 | ESPI MICRO SCISSORS, #8150 | Sep 12, 1990 | Substantially Equivalent |
| K903601 | ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204 | Sep 12, 1990 | Substantially Equivalent |
| K903595 | ESPI CLAW FORCEP, #8302, 10MM, 30CM | Sep 12, 1990 | Substantially Equivalent |
| K903602 | ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203 | Sep 12, 1990 | Substantially Equivalent |
| K903592 | ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH | Sep 12, 1990 | Substantially Equivalent |
| K903594 | ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201 | Sep 12, 1990 | Substantially Equivalent |