FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PILLING LAPAROSCOPIC INSTRUMENTATION
K Number: K934427
·
Decision Jan 10, 1994
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
39
Review Days
122
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Basic Information
- Device Name
- PILLING LAPAROSCOPIC INSTRUMENTATION
- K Number
- K934427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pilling Co.
- Date Received
- September 10, 1993
- Decision Date
- January 10, 1994
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Pilling Co.
| K Number | Device Name | ||
|---|---|---|---|
| K925370 | TRIANGULAR JAW MICROLARYNGEAL FORCEPS | Mar 18, 1993 | Substantially Equivalent |
| K925198 | KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR | Feb 12, 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 |