FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGIMAT
K Number: K926259
·
Decision Sep 14, 1994
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
26
Review Days
635
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
- SURGIMAT
- K Number
- K926259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- W.O.M. World of Medicine GmbH
- Date Received
- December 18, 1992
- Decision Date
- September 14, 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 W.O.M. World of Medicine GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K250795 | PUREVUE FMS | Dec 5, 2025 | Substantially Equivalent |
| K201361 | PNEUMOCLEAR | Jul 29, 2020 | Substantially Equivalent |
| K173311 | ARTHRO-Pump PA304 | May 9, 2018 | Substantially Equivalent |
| K173489 | GYN-Pump PH304 | Mar 28, 2018 | Substantially Equivalent |
| K172040 | Aquilex Fluid Control System AQL-100S | Feb 5, 2018 | Substantially Equivalent |
| K170784 | PNEUMOCLEAR | May 15, 2017 | Substantially Equivalent |
| K163320 | LAP-Pump PP110 | Mar 21, 2017 | Substantially Equivalent |
| K153513 | Insufflator 50L FM134 | Mar 4, 2016 | Substantially Equivalent |
| K152109 | HD-Camera HDC1000 | Oct 13, 2015 | Substantially Equivalent |
| K011175 | W.O.M. LASER U100 | Nov 1, 2001 | Substantially Equivalent |