FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMCATH COAGULATION PROBE
K Number: K902555
·
Decision Jun 20, 1990
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
10
Applicant Total
17
Review Days
12
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Basic Information
- Device Name
- AMCATH COAGULATION PROBE
- K Number
- K902555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Medical, Inc.
- Date Received
- June 8, 1990
- Decision Date
- June 20, 1990
- Product Code
- HFG
- 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 |
|---|---|---|---|
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by Intl. Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970507 | PEAK FLOW METER | Jun 13, 1997 | Substantially Equivalent |
| K943078 | HOT BIOPSY FORCEPS | Nov 14, 1994 | 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 |