510(k) K951197
K951197 is an FDA 510(k) premarket notification submitted by Pentax Precision Instrument Corp. for the device "FE-24X, FIBER ESOPHAGOSCOPE". The FDA issued a decision of Substantially Equivalent on May 30, 1995. The device falls under product code GCL (Esophagoscope, General & Plastic Surgery), a Class II device regulated under 21 CFR 876.1500. Pentax Precision Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 1995
- Date Received
- March 16, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esophagoscope, General & Plastic Surgery
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
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).