FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR
K Number: K925198
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
39
Review Days
119
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Basic Information
- Device Name
- KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR
- K Number
- K925198
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pilling Co.
- Date Received
- October 16, 1992
- Decision Date
- February 12, 1993
- 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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Other Clearances by Pilling Co.
| K Number | Device Name | ||
|---|---|---|---|
| K934427 | PILLING LAPAROSCOPIC INSTRUMENTATION | Jan 10, 1994 | Substantially Equivalent |
| K925370 | TRIANGULAR JAW MICROLARYNGEAL FORCEPS | Mar 18, 1993 | Substantially Equivalent |
| K922971 | NO-SCALPEL VASCETOMY INSTRUMENTS | Sep 23, 1992 | Substantially Equivalent |
| K914015 | CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP | Nov 21, 1991 | Substantially Equivalent |
| K911099 | MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE | Jun 25, 1991 | Substantially Equivalent |
| K911100 | MEHIGAN-PILLING PHLEBETOME TM | Jun 21, 1991 | Substantially Equivalent |
| K904507 | PILLING BRUSH VALVULOTOME | Mar 1, 1991 | Substantially Equivalent |
| K884946 | JEHLE CORONARY PERFUSION CATHETERS | Feb 6, 1989 | Substantially Equivalent |
| K882930 | LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX | Aug 16, 1988 | Substantially Equivalent |
| K874242 | JEHLE CORONARY PERFUSION CATHETERS | Dec 7, 1987 | Substantially Equivalent |