Xenon Arc Endoscope Light Source
FDA 510(k) K920403 · Medical Device Inspection Co., Inc.
510(k) numberK920403
Submission
- Device name
- Xenon Arc Endoscope Light Source
- Applicant
- Medical Device Inspection Co., Inc.
Great Neck, NY, US - Received
- January 31, 1992
- Decision date
- February 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
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| K922045 | Shower ChairsINM · Traditional | 05/26/1992SE |
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| K914174 | Sterile Disposable Wet Skin Scrub TrayLRO · Traditional | 02/24/1992SEKD |
Questions and answers
When was Xenon Arc Endoscope Light Source cleared by the FDA?
Xenon Arc Endoscope Light Source (K920403) received a 510(k) decision of Substantially Equivalent on February 21, 1992, 21 days after the submission was received.
What is the product code of K920403?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.