K923555 is an FDA 510(k) clearance for the CODMAN GAAB NEUROENDOSCOPE. This device is classified as a Antisera, Fluorescent, All Types, Streptococcus Pneumoniae (Class I - General Controls, product code GWB).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on March 23, 1993, 249 days after receiving the submission on July 17, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K923555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1992 |
| Decision Date | March 23, 1993 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GWB - Antisera, Fluorescent, All Types, Streptococcus Pneumoniae |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |