FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR
K Number: K992027
·
Decision Sep 9, 1999
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
170
Applicant Total
35
Review Days
85
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
- KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR
- K Number
- K992027
- 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
- June 16, 1999
- Decision Date
- September 9, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIH), ordered by most recent decision date.
Strauss Surgical Resection Instruments
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Manual Tissue Removal Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
InnovexView (GC146-17, GC150-20, GC155-23)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPY Cystoscope/Hysteroscope
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RZ Resectoscope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Karl Storz Endoscopy
| K Number | Device Name | ||
|---|---|---|---|
| K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES | Jan 24, 2005 | Substantially Equivalent |
| K030848 | PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX | Jun 2, 2003 | Substantially Equivalent |
| K030009 | KSEA POWERSHAVER SYSTEM S2 | Apr 2, 2003 | Substantially Equivalent |
| 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 |