FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POOLE TIP SUCTION PROBE
K Number: K915762
·
Decision Mar 13, 1992
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
13
Applicant Total
34
Review Days
80
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Basic Information
- Device Name
- POOLE TIP SUCTION PROBE
- K Number
- K915762
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- O.R. Concepts, Inc.
- Date Received
- December 24, 1991
- Decision Date
- March 13, 1992
- 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
Other 510(k) clearances with the same product code (GCI), ordered by most recent decision date.
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FDA Class 2
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GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by O.R. Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941337 | FLOWGUN ELECTROCAUTERY PROBES | Aug 17, 1994 | Substantially Equivalent |
| K935970 | FLOWGUN ELECTROCAUTERY PROBE HANDLE | May 16, 1994 | Substantially Equivalent |
| K935971 | FLOWGUN ELECTROCAUTERY PROBES | May 16, 1994 | Substantially Equivalent |
| K935645 | FLOWGUN REUSABLE IRRIGATION PROBES | Mar 7, 1994 | Substantially Equivalent |
| K926242 | ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE | Oct 15, 1993 | Substantially Equivalent |
| K922244 | INSUFFLATOR TUBING/FILTER KIT | Sep 24, 1993 | Substantially Equivalent |
| K922197 | INSUFFLATOR TUBING KIT | Sep 24, 1993 | Substantially Equivalent |
| K932449 | DR. FOG | Aug 11, 1993 | Substantially Equivalent |
| K925147 | ORC 10.0MM SUCTION PROBE | Jun 25, 1993 | Substantially Equivalent |
| K925024 | ORC TAPPERED IRRIGATING PROBE | May 21, 1993 | Substantially Equivalent |