Dci Endoscope
FDA 510(k) K993539 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK993539
Submission
- Device name
- Dci Endoscope
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- October 19, 1999
- Decision date
- December 15, 1999
- 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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| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 07/28/2023SE |
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| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
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Questions and answers
When was Dci Endoscope cleared by the FDA?
Dci Endoscope (K993539) received a 510(k) decision of Substantially Equivalent on December 15, 1999, 57 days after the submission was received.
What is the product code of K993539?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.