FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
O.R. CONCEPTS' IRRIGATING KITTNER
K Number: K923818
·
Decision Apr 7, 1993
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
34
Review Days
251
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Basic Information
- Device Name
- O.R. CONCEPTS' IRRIGATING KITTNER
- K Number
- K923818
- 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
- July 30, 1992
- Decision Date
- April 7, 1993
- Product Code
- FGS
- 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 |
|---|---|---|---|
| FGS | Carrier, Sponge, Endoscopic | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGS), ordered by most recent decision date.
QB II BLUNT DISSECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOSCOPIC BLUNT DISSECTING INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOSCOPIC SPONGE CARRIER
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 |