FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OTT INSUFFLATOR FILTER PLUS/TUBING SET
K Number: K914153
·
Decision Apr 2, 1992
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
28
Review Days
199
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Basic Information
- Device Name
- OTT INSUFFLATOR FILTER PLUS/TUBING SET
- K Number
- K914153
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Marlo Surgical Technology
- Date Received
- September 16, 1991
- Decision Date
- April 2, 1992
- Product Code
- HIF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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| K924611 | IRRIGATION PUMP AND TUBING SET | Jun 30, 1994 | Substantially Equivalent |
| K932634 | NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES | Feb 25, 1994 | Substantially Equivalent |
| K932832 | PRIMUS INSULATED FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K920611 | MARLOW LAPAROSCOPIC GRASPING FORCEP | Apr 20, 1993 | Substantially Equivalent |
| K914869 | MARLOW LAPAROSCOPIC SCISSORS | Jan 15, 1992 | Substantially Equivalent |
| K913954 | MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS | Dec 18, 1991 | Substantially Equivalent |
| K914872 | MARLOW SUCTION/IRRIGATION PROBES | Nov 19, 1991 | Substantially Equivalent |
| K913964 | MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS | Oct 23, 1991 | Substantially Equivalent |