Codman(R) Ridig and Steerable Endoscope Holder, Model 83-1352
FDA 510(k) K945572 · Johnson & Johnson Professionals, Inc.
510(k) numberK945572
Submission
- Device name
- Codman(R) Ridig and Steerable Endoscope Holder, Model 83-1352
- Applicant
- Johnson & Johnson Professionals, Inc.
Raritan, NJ, US - Received
- November 14, 1994
- Decision date
- February 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GWG – Endoscope, Neurological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1480
- Specialty
- Neurology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Codman(R) Ridig and Steerable Endoscope Holder, Model 83-1352 cleared by the FDA?
Codman(R) Ridig and Steerable Endoscope Holder, Model 83-1352 (K945572) received a 510(k) decision of Substantially Equivalent on February 3, 1995, 81 days after the submission was received.
What is the product code of K945572?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.