Endoscopic Instrument
FDA 510(k) K791052 · Eder Instrument Co, Inc.
510(k) numberK791052
Submission
- Device name
- Endoscopic Instrument
- Applicant
- Eder Instrument Co, Inc.
Walker, MI, US - Received
- June 6, 1979
- Decision date
- August 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HET
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230)HET · Traditional | Precision Robotics (Hong Kong) Limited | 08/29/2025SE |
| K243821 | i-CutHET · Traditional | A.M.I. Agency For Medical Innovations GmbH | 04/25/2025SE |
| K221642 | SIRIUS Endoscope SystemHET · Traditional | Precision Robotics (Hong Kong) Limited | 12/12/2022SE |
| K210116 | Video Endoscopy System, 3D Video Endoscopy SystemHET · Traditional | Surgnova Healthcare Technologies (Zhejiang) Co.… | 10/13/2021SE |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5HET · Traditional | Olympus Medical Systems Corp. | 09/17/2021SE |
| K210104 | SurroundScope SystemHET · Traditional | 270surgical , Ltd. | 07/08/2021SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | Schoelly Fiberoptic GmbH | 03/12/2021SE |
| K200216 | 4K UHD Camera SystemHET · Traditional | Scivita Medical Technology Co., Ltd. | 08/21/2020SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K843498 | Bipolar Suction ElectrodeGET · Traditional | 12/14/1984SE |
| K843499 | Arthroscopy Leg Holder · Traditional | 10/31/1984SE |
| K843497 | Surgical Knives & ProbesEMF · Traditional | 10/31/1984SE |
| K831255 | Laryngoscope Attachment PH2000EQN · Traditional | 09/12/1983SE |
| K831240 | Laser BronchoscopeEOQ · Traditional | 07/26/1983SE |
| K831241 | Laser LaparaxopeHET · Traditional | 06/10/1983SE |
| K822959 | Endoscopic VideosystemFET · Traditional | 10/22/1982SE |
| K802479 | Surgical Knives & ProbesHXB · Traditional | 10/31/1980SE |
| K792100 | Grasping Forcep (W/Four Prongs)GEN · Traditional | 11/13/1979SE |
Questions and answers
When was Endoscopic Instrument cleared by the FDA?
Endoscopic Instrument (K791052) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 58 days after the submission was received.
What is the product code of K791052?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.