MITYVAC
FDA 510(k) clearance K011532 · decided 2001-07-30
Clearance details
- K-number
- K011532
- Device name
- MITYVAC
- Applicant
- Prism Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-18
- Decision date
- 2001-07-30
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- HDB
- Device class
- 2
- Regulation number
- 884.4340
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). P recall (Z-1887-2008) | Cooper Surgical, Inc. | 2008-09-17 |
| M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted De recall (Z-1888-2008) | Cooper Surgical, Inc. | 2008-09-17 |
| Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is in recall (Z-1889-2008) | Cooper Surgical, Inc. | 2008-09-17 |
| Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047 recall (Z-0005-05) | CooperSurgical, Inc. | 2004-10-05 |