FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRASPING FORCEPS FLEXIBLE STONE DISLODGER
K Number: K930499
·
Decision Aug 16, 1993
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
73
Applicant Total
7
Review Days
196
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Basic Information
- Device Name
- GRASPING FORCEPS FLEXIBLE STONE DISLODGER
- K Number
- K930499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endomedix
- Date Received
- February 1, 1993
- Decision Date
- August 16, 1993
- Product Code
- OCZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Endomedix
| K Number | Device Name | ||
|---|---|---|---|
| K934170 | ENDOMEDIX Y-ADAPTER | Jan 11, 1994 | Substantially Equivalent |
| K934623 | ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA | Dec 2, 1993 | Substantially Equivalent |
| K930349 | STONE RETRIEVAL BASKET | Jun 9, 1993 | Substantially Equivalent |
| K926004 | ENDOSCOPE AND ACCOSSORIES | Feb 10, 1993 | Substantially Equivalent |
| K922837 | S1500 XENON LIGHT SOURCE | Nov 3, 1992 | Substantially Equivalent |
| K922082 | LAPAROSCOPIC INTRODUCER | Aug 3, 1992 | Substantially Equivalent |