Endoscope and Accessories
FDA 510(k) K790071 · Olympus Corp.
510(k) numberK790071
Submission
- Device name
- Endoscope and Accessories
- Applicant
- Olympus Corp.
Walker, MI, US - Received
- January 11, 1979
- Decision date
- April 2, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCP – Endoscope, Ac-Powered And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954614 | Eos Brand Disposable ProctoscopeGCP · Traditional | North Eos Industries, Inc. | 04/10/1996SE |
| K896505 | Porges Universal HandlesGCP · Traditional | Porges Corp. | 01/30/1990SE |
| K896008 | Model 6500 Mercury Arc Light SourceGCP · Traditional | Medical Dynamics, Inc. | 12/27/1989SE |
| K862424 | Steerable Catheter SystemGCP · Traditional | Endovations | 09/22/1986SE |
| K860103 | Mod. Endoport Single-Use Trocar and SleeveGCP · Traditional | Endotherapeutics | 02/12/1986SE |
| K843683 | Modular Fiberscope SystemGCP · Traditional | Reichert Scientific Instruments | 01/18/1985SE |
| K833859 | Tamponade Balloon CuffGCP · Traditional | American Endoscopy, Inc. | 01/03/1984SE |
| K821999 | Endoscopic Sclerotherapy BalloonGCP · Traditional | Retech | 08/27/1982SE |
| K801247 | CCD Endoscope and AttachmentsGCP · Traditional | Welch Allyn, Inc. | 07/28/1980SE |
| K771920 | Fiber Optics ProctoscopeGCP · Traditional | Propper Mfg. Co., Inc. | 10/20/1977SE |
More from Propper Mfg. Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K072643 | Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/USKZN · Traditional | 11/16/2007SE |
| 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 |
| K942338 | Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesFDT · Traditional | 11/30/1994SE |
| K931763 | Hf-Resection Electrode, Loop W/Runner Endos/AccessFAS · Traditional | 08/29/1994SE |
| K934835 | FlovalFJL · Traditional | 06/21/1994SE |
Questions and answers
When was Endoscope and Accessories cleared by the FDA?
Endoscope and Accessories (K790071) received a 510(k) decision of Substantially Equivalent on April 2, 1979, 81 days after the submission was received.
What is the product code of K790071?
The FDA product code is GCP – Endoscope, Ac-Powered And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.