APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
FDA 510(k) clearance K050256 · decided 2005-04-26
Clearance details
- K-number
- K050256
- Device name
- APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
- Applicant
- Apple Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-03
- Decision date
- 2005-04-26
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- GAD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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| CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (K980588) | Clarus Medical Systems, Inc. | 1998-08-18 |
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| VILLALTA RETRACTOR (K943875) | Hct, Inc. | 1994-11-09 |
| RETRACTOR (K942002) | Automated Medical Products Corp. | 1994-05-17 |
| RETRACTOR (K941448) | Technovations | 1994-04-15 |
| LUNG RETRACTORS: DAVIDSON, SEMB (K930316) | Thomasville Medical Assoc. | 1994-02-10 |
Recalls involving this device
No recalls on record reference this clearance.