FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADAPTER, FIBER OPTICS HEADLIGHT
K Number: K760647
·
Decision Dec 6, 1976
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
30
Applicant Total
39
Review Days
82
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Basic Information
- Device Name
- ADAPTER, FIBER OPTICS HEADLIGHT
- K Number
- K760647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Pilling Co.
- Date Received
- September 15, 1976
- Decision Date
- December 6, 1976
- Product Code
- FCW
- 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 |
|---|---|---|---|
| FCW | Light Source, Fiberoptic, Routine | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| 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 |