The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fg-36ux, Fiber Ultrasound Gastroscope.
| Device ID | K010740 |
| 510k Number | K010740 |
| Device Name: | FG-36UX, FIBER ULTRASOUND GASTROSCOPE |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Paul Silva |
| Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-13 |
| Decision Date | 2001-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333224463 | K010740 | 000 |
| 04961333169054 | K010740 | 000 |
| 04961333239382 | K010740 | 000 |