MINI-MICRO ARTHROSCOPIC SCAPEL
FDA 510(k) clearance K820777 · decided 1982-05-12
Clearance details
- K-number
- K820777
- Device name
- MINI-MICRO ARTHROSCOPIC SCAPEL
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-23
- Decision date
- 1982-05-12
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx O recall (Z-1914-2014) | The Anspach Effort, Inc. | 2014-06-25 |