FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K Number: K980976
·
Decision Aug 21, 1998
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
29
Applicant Total
85
Review Days
158
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Basic Information
- Device Name
- AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
- K Number
- K980976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4340
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hollister, Inc.
- Date Received
- March 16, 1998
- Decision Date
- August 21, 1998
- 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)
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VACULINK, MODEL VCL 3000
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FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
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MITYVAC MERLIN, MODEL 10027
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SWIFT LOW PROFILE CUP (PRO CUP)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Hollister, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K123804 | INSTAFLO BOWEL CATHETER SYSTEM KIT | Apr 17, 2013 | Substantially Equivalent |
| K100273 | INSTAFLO BOWEL CATHETER SYSTEM KIT | Apr 22, 2010 | Unknown |
| K090960 | VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, | Aug 20, 2009 | Substantially Equivalent |
| K083153 | ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 | Feb 4, 2009 | Unknown |
| K050483 | EVADRI BLADDER CONTROL SYSTEMS | Apr 12, 2005 | Substantially Equivalent |
| K040779 | RESTORE WOUND CLEANSER | May 17, 2004 | Substantially Equivalent |
| K013612 | INCARE PELVIC FLOOR THERAPY SYSTEM | Mar 19, 2002 | Substantially Equivalent |
| K013653 | INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE | Mar 5, 2002 | Substantially Equivalent |
| K013483 | INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT | Jan 14, 2002 | Substantially Equivalent |
| K013345 | INCARE INTERMITTENT CATHETER | Jan 7, 2002 | Substantially Equivalent |