FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYS-SURGIFLATOR 150P
K Number: K983889
·
Decision Jan 14, 1999
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
55
Applicant Total
26
Review Days
73
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Basic Information
- Device Name
- HYS-SURGIFLATOR 150P
- K Number
- K983889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1700
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W.O.M. World of Medicine GmbH
- Date Received
- November 2, 1998
- Decision Date
- January 14, 1999
- Product Code
- HIG
- 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 |
|---|---|---|---|
| HIG | Insufflator, Hysteroscopic | FDA class 2 | Obstetrics/Gynecology |
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| 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 |