Codman Gaab Neuroendoscope
FDA 510(k) K923555 · Codman & Shurtleff, Inc.
510(k) numberK923555
Submission
- Device name
- Codman Gaab Neuroendoscope
- Applicant
- Codman & Shurtleff, Inc.
Randolph, MA, US - Received
- July 17, 1992
- Decision date
- March 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWB – Antisera, Fluorescent, All Types, Streptococcus Pneumoniae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code GWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K760816 | Pneumotachography SystemGWB · Traditional | Aftercal, Inc. | 10/29/1976SE |
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Questions and answers
When was Codman Gaab Neuroendoscope cleared by the FDA?
Codman Gaab Neuroendoscope (K923555) received a 510(k) decision of Substantially Equivalent on March 23, 1993, 249 days after the submission was received.
What is the product code of K923555?
The FDA product code is GWB – Antisera, Fluorescent, All Types, Streptococcus Pneumoniae, a Class I (low risk) device regulated under 21 CFR 866.3740.