FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PNEUMOCLEAR
K Number: K170784
·
Decision May 15, 2017
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
26
Review Days
61
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
- PNEUMOCLEAR
- K Number
- K170784
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W.O.M. World of Medicine GmbH
- Date Received
- March 15, 2017
- Decision Date
- May 15, 2017
- Product Code
- HIF
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIF), ordered by most recent decision date.
Insufflator (OPTO-IFL1000)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOFLATOR +
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AirSurgN Insufflator (10030/AirSurgN)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
High Flow Insufflation Unit (UHI-4)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TauTona Pneumoperitoneum Assist Device (TPAD)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VereSee Optical Veres Needle 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 |
| 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 |
| K000153 | ARTHRO-SURGIMAT-A103 | Feb 8, 2000 | Substantially Equivalent |