MSS-28CS-301/701 Needlescope
FDA 510(k) K013759 · Olympus Optical Co., Ltd.
510(k) numberK013759
Submission
- Device name
- MSS-28CS-301/701 Needlescope
- Applicant
- Olympus Optical Co., Ltd.
Melville, NY, US - Received
- November 13, 2001
- Decision date
- August 20, 2002
- 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 MSS-28CS-301/701 Needlescope cleared by the FDA?
MSS-28CS-301/701 Needlescope (K013759) received a 510(k) decision of Substantially Equivalent on August 20, 2002, 280 days after the submission was received.
What is the product code of K013759?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.