IE MAGNETIC EXTRACTOR
FDA 510(k) clearance K904668 · decided 1991-03-21
Clearance details
- K-number
- K904668
- Device name
- IE MAGNETIC EXTRACTOR
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-15
- Decision date
- 1991-03-21
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- FCC
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BRIMFIELD CANNULATED MAGNETIC RETRIEVER (K843135) | Brimfield Scientific Instruments | 1984-09-26 |
| M.R. ASSOC. MAGNETIC EXTRACTOR (K800971) | Mr Associates, Inc. | 1980-05-08 |
Recalls involving this device
No recalls on record reference this clearance.