FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYNECOLOGICAL LAPAROSCOPES
K Number: K003805
·
Decision Jul 22, 2001
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
7
Review Days
226
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Basic Information
- Device Name
- GYNECOLOGICAL LAPAROSCOPES
- K Number
- K003805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Global Endoscopy, Inc.
- Date Received
- December 8, 2000
- Decision Date
- July 22, 2001
- 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 Global Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003802 | HYSTEROSCOPES | Jul 22, 2001 | Substantially Equivalent |
| K003831 | ARTHROSCOPES | Jul 20, 2001 | Substantially Equivalent |
| K003830 | ENT ENDOSCOPES | Apr 9, 2001 | Substantially Equivalent |
| K003803 | GENERAL SURGICAL LAPAROSCOPES | Mar 7, 2001 | Substantially Equivalent |
| K003806 | URETEROSCOPES | Feb 22, 2001 | Substantially Equivalent |
| K003807 | CYSTOSCOPES | Feb 22, 2001 | Substantially Equivalent |