FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOT BIOPSY FORCEPS
K Number: K943078
·
Decision Nov 14, 1994
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
17
Review Days
139
Basic Information
- Device Name
- HOT BIOPSY FORCEPS
- K Number
- K943078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- INTL. MEDICAL, INC.
- Date Received
- June 28, 1994
- Decision Date
- November 14, 1994
- 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 INTL. MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K970507 | PEAK FLOW METER | Jun 13, 1997 | Substantially Equivalent |
| K940370 | AMERICAN CATHETER E.R.C.P. CANNULA | Aug 17, 1994 | Substantially Equivalent |
| K940335 | AMERICAN CATHETER POLY-SNARE | Jul 21, 1994 | Substantially Equivalent |
| K942068 | AMERICAN CATHETER SPHINCTEROTOME | Jun 24, 1994 | Substantially Equivalent |
| K930406 | DURHAM; MIN BORE LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K930410 | DURHAM; LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K923200 | AMCATH DISPOSABLE CYTOLOGY BRUSH | Dec 7, 1992 | Substantially Equivalent |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | Jan 10, 1992 | Substantially Equivalent |
| K912927 | AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE | Sep 19, 1991 | Substantially Equivalent |
| K912605 | AMCATH DISPOSABLE MICRO SCISSORS | Jul 11, 1991 | Substantially Equivalent |