FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED
K Number: K923260
·
Decision Jun 9, 1994
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
28
Review Days
707
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
- LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED
- K Number
- K923260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Imtec Corp.
- Date Received
- July 2, 1992
- Decision Date
- June 9, 1994
- 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 Imtec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM | Sep 19, 2008 | Substantially Equivalent |
| K081347 | ILUMA VISION | May 28, 2008 | Substantially Equivalent |
| K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 | Dec 12, 2007 | Substantially Equivalent |
| K053046 | ILUMA ORTHOCAT/DENTALCAT | Nov 8, 2005 | Substantially Equivalent |
| K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 | Jan 13, 2005 | Substantially Equivalent |
| K042289 | MDI ORTHO | Sep 15, 2004 | Substantially Equivalent |
| K033432 | LEXATITE QUICK ACRYLIC | Jan 15, 2004 | Substantially Equivalent |
| K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX | Aug 12, 2003 | Substantially Equivalent |
| K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | Apr 23, 2003 | Substantially Equivalent |
| K024044 | SABER TECH IMPLANTS SYSTEM | Feb 21, 2003 | Substantially Equivalent |