FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OBSTETRICAL VACUUM CUP
K Number: K911326
·
Decision Aug 14, 1991
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
29
Applicant Total
26
Review Days
141
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Basic Information
- Device Name
- OBSTETRICAL VACUUM CUP
- K Number
- K911326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4340
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Gesco Intl., Inc.
- Date Received
- March 26, 1991
- Decision Date
- August 14, 1991
- Product Code
- HDB
- 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 |
|---|---|---|---|
| HDB | Extractor, Vacuum, Fetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HDB), ordered by most recent decision date.
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VACULINK, MODEL VCL 3000
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MITYVAC MERLIN, MODEL 10027
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SWIFT LOW PROFILE CUP (PRO CUP)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Gesco Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954422 | PER-Q-CATH MID-LINE | Dec 15, 1995 | Substantially Equivalent |
| K940953 | UMBILI-CATH-S | Aug 2, 1994 | Substantially Equivalent |
| K940870 | UMBILI-CATH | Aug 2, 1994 | Substantially Equivalent |
| K940952 | UMBILI-CATH-S-DL | Jul 29, 1994 | Substantially Equivalent |
| K941672 | URI-CATH CATHETER | May 16, 1994 | Substantially Equivalent |
| K941232 | THORA-CATH | May 11, 1994 | Substantially Equivalent |
| K940871 | UMBILI-CATH-P | Apr 29, 1994 | Substantially Equivalent |
| K931989 | VENTRI-CATH | Jul 21, 1993 | Substantially Equivalent |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | Jun 7, 1993 | Unknown |
| K923591 | PALA-NATE | Mar 16, 1993 | Substantially Equivalent |