FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOPSY FORCEPS
K Number: K914497
·
Decision Jan 3, 1992
Classifications
1
FEI Numbers
188
Registration Numbers
188
Same Product Code
38
Applicant Total
11
Review Days
87
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Basic Information
- Device Name
- BIOPSY FORCEPS
- K Number
- K914497
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Surgitek Medical Engineering Corp.
- Date Received
- October 8, 1991
- Decision Date
- January 3, 1992
- Product Code
- FCL
- 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 |
|---|---|---|---|
| FCL | Forceps, Biopsy, Non-Electric | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by Surgitek Medical Engineering Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K914504 | CYTOLOGY BRUSH | Feb 18, 1992 | Substantially Equivalent |
| K914495 | E.R.C.P. CATHETER | Jan 30, 1992 | Substantially Equivalent |
| K914505 | STONE BASKET | Dec 9, 1991 | Substantially Equivalent |
| K914496 | SCLEROTHERAPY NEEDLE | Dec 5, 1991 | Substantially Equivalent |
| K914503 | GRASPING FORCEPS | Dec 5, 1991 | Substantially Equivalent |
| K913928 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT | Nov 19, 1991 | Substantially Equivalent |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | Oct 4, 1991 | Substantially Equivalent |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | Jun 25, 1991 | Substantially Equivalent |
| K910768 | SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE | Mar 19, 1991 | Substantially Equivalent |
| K903127 | SURGITEK(R) TURP MONITOR | Oct 9, 1990 | Substantially Equivalent |