FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORC 10.0MM SUCTION PROBE
K Number: K925147
·
Decision Jun 25, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
34
Review Days
255
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Basic Information
- Device Name
- ORC 10.0MM SUCTION PROBE
- K Number
- K925147
- 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
- October 13, 1992
- Decision Date
- June 25, 1993
- Product Code
- GCJ
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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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 |
| K925024 | ORC TAPPERED IRRIGATING PROBE | May 21, 1993 | Substantially Equivalent |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | May 17, 1993 | Substantially Equivalent |