FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OTT CERVICAL TENACULUM
K Number: K910287
·
Decision Feb 28, 1991
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
19
Applicant Total
28
Review Days
37
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Basic Information
- Device Name
- OTT CERVICAL TENACULUM
- K Number
- K910287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Marlo Surgical Technology
- Date Received
- January 22, 1991
- Decision Date
- February 28, 1991
- Product Code
- HDC
- 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 |
|---|---|---|---|
| HDC | Tenaculum, Uterine | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDC), ordered by most recent decision date.
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ASPIVIX v1.1 Cervical Suction Tenaculum
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Bioceptive Suction Cervical Retractor
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JARIT HULKA UTERINE TENACULUM FORCEPS
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GYN DISPOSABLES TENACULUM 356T
FDA 510(k)
FDA Class 2
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FEMTEN CERVICAL TENACULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Marlo Surgical Technology
| K Number | Device Name | ||
|---|---|---|---|
| K960810 | BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM | Oct 21, 1996 | Substantially Equivalent |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Jul 31, 1996 | Substantially Equivalent |
| 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 |
| K914153 | OTT INSUFFLATOR FILTER PLUS/TUBING SET | Apr 2, 1992 | 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 |