FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE
K Number: K990411
·
Decision May 11, 1999
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
170
Applicant Total
35
Review Days
90
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Basic Information
- Device Name
- MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE
- K Number
- K990411
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Karl Storz Endoscopy
- Date Received
- February 10, 1999
- Decision Date
- May 11, 1999
- Product Code
- HIH
- 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 |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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| K023924 | AUTOCON II 200 ELECTROSURGICAL GENERATOR | Feb 21, 2003 | Substantially Equivalent |
| K023187 | KSEA SPINOSCOPE | Dec 2, 2002 | Substantially Equivalent |
| K011700 | MODULITH SLK LITHOTRIPTER | Aug 16, 2002 | Substantially Equivalent |
| K021776 | KSEA QUADRO SWITCH | Aug 15, 2002 | Substantially Equivalent |
| K013107 | BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | Feb 26, 2002 | Substantially Equivalent |
| K011841 | KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR | Sep 10, 2001 | Substantially Equivalent |
| K010569 | KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP | Apr 9, 2001 | Substantially Equivalent |