FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOPORT 5MM
K Number: K852031
·
Decision Aug 13, 1985
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
7
Review Days
96
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ENDOPORT 5MM
- K Number
- K852031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Endotherapeutics
- Date Received
- May 9, 1985
- Decision Date
- August 13, 1985
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HET), ordered by most recent decision date.
SIRIUS Endoscope System (PR-SI-1230)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
i-Cut
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIRIUS Endoscope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Video Endoscopy System, 3D Video Endoscopy System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SurroundScope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Endotherapeutics
| K Number | Device Name | ||
|---|---|---|---|
| K870855 | UROSCAN | Jun 9, 1987 | Substantially Equivalent |
| K860192 | ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE | Mar 17, 1986 | Substantially Equivalent |
| K860102 | MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE | Feb 12, 1986 | Substantially Equivalent |
| K860103 | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | Feb 12, 1986 | Substantially Equivalent |
| K844619 | ENDONEEDLE | Jan 9, 1985 | Substantially Equivalent |
| K841716 | ENDOPORT EROCAR | Jun 28, 1984 | Substantially Equivalent |