LANCER BIOPSY HOLDER
FDA 510(k) clearance K772149 · decided 1977-11-22
Clearance details
- K-number
- K772149
- Device name
- LANCER BIOPSY HOLDER
- Applicant
- Sherwood Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1977-11-14
- Decision date
- 1977-11-22
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- KER
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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 |
|---|---|---|
| EMBEDDING RING (K831922) | Polymer Technology Corp. | 1983-07-29 |
| MACLEAN-FOGG, DISP. BASE MOLD (K831900) | Polymer Technology Corp. | 1983-07-28 |
| EMBEDDING RINGS (K831333) | Surgipath Medical Industries, Inc. | 1983-05-25 |
| DISPOSABLE BASE MOLD (K831335) | Surgipath Medical Industries, Inc. | 1983-05-16 |
Recalls involving this device
No recalls on record reference this clearance.