MENISCOTOME
FDA 510(k) clearance K800732 · decided 1980-04-08
Clearance details
- K-number
- K800732
- Device name
- MENISCOTOME
- Applicant
- Stainless Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-01
- Decision date
- 1980-04-08
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- HXP
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| WILLIAMS VERTEBRAL SPREADER (K872858) | Ace Medical Co. | 1987-10-15 |
| RETROGRADE KNIFE (K800730) | Stainless Mfg., Inc. | 1980-04-08 |
| DOUBLE-EDGE CURETTE (K800733) | Stainless Mfg., Inc. | 1980-04-08 |
| MENISCAL SAW (K800731) | Stainless Mfg., Inc. | 1980-04-08 |
Recalls involving this device
No recalls on record reference this clearance.