TRI-PLEX ADAPTER
FDA 510(k) clearance K010401 · decided 2002-10-30
Clearance details
- K-number
- K010401
- Device name
- TRI-PLEX ADAPTER
- Applicant
- The Medical Device Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-12
- Decision date
- 2002-10-30
- Days to decision
- 625 days
- Clearance type
- Traditional
- Product code
- MOD
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tri-Plex Adapter, single unit (MD-04000 )or box of 25 (MD-04001) or case of 100 (MD-04002) recall (Z-1371-05) | Medical Device Group Inc. | 2005-08-16 |