Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
FDA 510(k) K002572 · Medtronic PS Medical
510(k) numberK002572
Submission
- Device name
- Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
- Applicant
- Medtronic PS Medical
Goleta, CA, US - Received
- August 18, 2000
- Decision date
- November 16, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | Integra LifeSciences Corporation | 04/09/2025SE |
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| K232618 | Aurora Surgiscope SystemGWG · Traditional | Rebound Therapeutics Corporation | 10/27/2023SE |
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| K232159 | QEVO SystemGWG · Special | Carl Zeiss Meditec, AG | 09/21/2023SE |
| K222735 | HJY VisualNext Endoscopic Vision SystemGWG · Traditional | Hjy Smart Medical Device Co., Ltd. | 07/28/2023SE |
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| K983799 | Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System…GWM · Traditional | 01/26/1999SE |
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Questions and answers
When was Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 cleared by the FDA?
Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 (K002572) received a 510(k) decision of Substantially Equivalent on November 16, 2000, 90 days after the submission was received.
What is the product code of K002572?
The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.