FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
5MM MICROSCISSORS
K Number: K913870
·
Decision Sep 16, 1991
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
37
Review Days
18
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Basic Information
- Device Name
- 5MM MICROSCISSORS
- K Number
- K913870
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Endovations
- Date Received
- August 29, 1991
- Decision Date
- September 16, 1991
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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| K911155 | OVAL CUP BIOPSY FORCEP | Aug 7, 1991 | Substantially Equivalent |
| K892218 | ENDO-SPONGE | May 31, 1989 | Substantially Equivalent |
| K883093 | TRANSENDOSCOPIC ASPIRATION NEEDLE | Dec 8, 1988 | Substantially Equivalent |
| K873360 | ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG | Mar 30, 1988 | Substantially Equivalent |
| K875264 | WASHING CATHETER | Mar 29, 1988 | Substantially Equivalent |
| K874062 | ENTERON LIVER BIOPSY TRAY | Dec 31, 1987 | Substantially Equivalent |