FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPE AND ACCESSORIES
K Number: K905117
·
Decision Apr 25, 1991
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
13
Applicant Total
55
Review Days
163
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Basic Information
- Device Name
- ENDOSCOPE AND ACCESSORIES
- K Number
- K905117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Northgate Technologies, Inc.
- Date Received
- November 13, 1990
- Decision Date
- April 25, 1991
- Product Code
- GCI
- 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 |
|---|---|---|---|
| GCI | Laryngoscope, Endoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
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FDA Class 2
·Gastroenterology, Urology
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|---|---|---|---|
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| K130368 | AUTOLITH TOUCH; URO TOUCH | Nov 15, 2013 | Substantially Equivalent |
| K120151 | NEBULAE I | Aug 17, 2012 | Substantially Equivalent |
| K041560 | FLO-ASSISTANT | Sep 28, 2004 | Substantially Equivalent |
| K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | Jul 29, 2004 | Substantially Equivalent |
| K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | Jan 24, 2003 | Substantially Equivalent |
| K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | Oct 23, 2001 | Substantially Equivalent |
| K011928 | HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 | Aug 10, 2001 | Substantially Equivalent |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | Aug 18, 2000 | Substantially Equivalent |