FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LAPAROSCOPIC SUCTION/IRRIGATION PROBE
K Number: K920643
·
Decision May 6, 1992
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
23
Applicant Total
34
Review Days
84
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Basic Information
- Device Name
- LAPAROSCOPIC SUCTION/IRRIGATION PROBE
- K Number
- K920643
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- O.R. Concepts, Inc.
- Date Received
- February 12, 1992
- Decision Date
- May 6, 1992
- Product Code
- GBZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GBZ | Catheter, Cholangiography | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBZ), ordered by most recent decision date.
PRE-VIEW CHOLANGIOGRAPHY CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOPATH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |