FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI-BITE HOT BIOPSY FORCEPS
K Number: K090796
·
Decision Nov 25, 2009
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
45
Applicant Total
7
Review Days
246
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Basic Information
- Device Name
- MULTI-BITE HOT BIOPSY FORCEPS
- K Number
- K090796
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Endo-Therapeutics, Inc.
- Date Received
- March 24, 2009
- Decision Date
- November 25, 2009
- Product Code
- KGE
- 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 |
|---|---|---|---|
| KGE | Forceps, Biopsy, Electric | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Endo-Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031026 | ETI BIPOLAR HEMOSTATIC PROBE | Jun 27, 2003 | Substantially Equivalent |
| K023603 | ENDO-GLIDE GUIDEWIRE | Feb 19, 2003 | Substantially Equivalent |
| K012725 | TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES | Nov 8, 2001 | Substantially Equivalent |
| K012977 | VARICES INJECTION NEEDLE | Nov 2, 2001 | Substantially Equivalent |
| K926549 | ENDOCATH ELECTROPHYSIOLOGY CATHETER | Dec 6, 1993 | Substantially Equivalent |
| K925392 | BIOPSY FORCEPS | Nov 5, 1993 | Substantially Equivalent |