510(k) K180292
K180292 is an FDA 510(k) premarket notification submitted by Pentax Medical Of America, Inc. for the device "PENTAX Video Upper G.I. Scope EG34-i10". The FDA issued a decision of Substantially Equivalent on Oct 12, 2018. The device falls under product code FDS (Gastroscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Pentax Medical Of America, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 12, 2018
- Date Received
- Feb 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastroscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
- 510(k)
To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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).