K811005 is an FDA 510(k) clearance for the CORB TM COUNTERROTATING BIOPSY NEEDLE. This device is classified as a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I - General Controls, product code HSZ).
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1981, 62 days after receiving the submission on April 14, 1981.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K811005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1981 |
| Decision Date | June 15, 1981 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |