Olympus PF-8P Oes Pancreato Fiberscope and Accessories
FDA 510(k) K942338 · Olympus Corp.
510(k) numberK942338
Submission
- Device name
- Olympus PF-8P Oes Pancreato Fiberscope and Accessories
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- May 16, 1994
- Decision date
- November 30, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDT – Duodenoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine the duodenum and to perform various procedures within the duodenum. 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).
Other 510(k)s with product code FDT
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|---|---|---|---|
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…FDT · Traditional | Fujifilm Corporation | 03/09/2026SE |
| K253646 | Single Use Distal Cover MAJ-2315 (MAJ-2315)FDT · Traditional | Olympus Medical Systems Corp. | 02/22/2026SE |
| K251867 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)FDT · Traditional | Olympus Medical Systems Corp. | 09/19/2025SE |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)FDT · Traditional | Olympus Medical Systems Corp. | 06/05/2025SE |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…FDT · Traditional | Pentax of America, Inc. | 08/01/2024SE |
| K233886 | Ambu® aScope Duodeno 2, Ambu® aBox 2FDT · Traditional | Ambu A/S | 04/16/2024SE |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190VFDT · Traditional | Olympus Medical Systems Corp. | 05/11/2022SE |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2FDT · Special | Pentax of America, Inc. | 04/09/2021SE |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10FDT · Traditional | Pentax of America, Inc. | 04/01/2021SE |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190VFDT · Traditional | Olympus Medical Systems Corp. | 12/08/2020SE |
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| K043128 | Olympus EndoarmGWG · Traditional | 12/21/2004SE |
| K042140 | Olympus BF Type UC160-OL8ODG · Traditional | 08/18/2004SE |
| K041494 | Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery UCES-2)…FET · Special | 07/01/2004SE |
| K040940 | Bronchovideoscope Olympus XBF-D160HMEOQ · Traditional | 04/19/2004SE |
| K915402 | EW-10 and EW-20FEB · Traditional | 06/23/1995SN |
| K933200 | Olympus PBD StentsFGE · Traditional | 04/05/1995SE |
| K931763 | Hf-Resection Electrode, Loop W/Runner Endos/AccessFAS · Traditional | 08/29/1994SE |
| K934835 | FlovalFJL · Traditional | 06/21/1994SE |
| K931764 | HF Resection Electrode, Loop W/Runner Hyster/AccesHIH · Traditional | 06/08/1994SE |
Questions and answers
When was Olympus PF-8P Oes Pancreato Fiberscope and Accessories cleared by the FDA?
Olympus PF-8P Oes Pancreato Fiberscope and Accessories (K942338) received a 510(k) decision of Substantially Equivalent on November 30, 1994, 198 days after the submission was received.
What is the product code of K942338?
The FDA product code is FDT – Duodenoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.