Scope Antifogging System
FDA 510(k) K182080 · Xodus Medical, Inc.
510(k) numberK182080
Submission
- Device name
- Scope Antifogging System
- Applicant
- Xodus Medical, Inc.
New Kensington, PA, US - Received
- August 2, 2018
- Decision date
- September 19, 2018
- 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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| 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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Questions and answers
When was Scope Antifogging System cleared by the FDA?
Scope Antifogging System (K182080) received a 510(k) decision of Substantially Equivalent on September 19, 2018, 48 days after the submission was received.
What is the product code of K182080?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.