Smith & Nephew Dyonics Inc. Electronic Endoscope
FDA 510(k) K936071 · Smith & Nephew Dyonics, Inc.
510(k) numberK936071
Submission
- Device name
- Smith & Nephew Dyonics Inc. Electronic Endoscope
- Applicant
- Smith & Nephew Dyonics, Inc.
Oklahoma City, OK, US - Received
- December 20, 1993
- Decision date
- August 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K955914 | Limited Reuse Arthroscopic BladesHRX · Traditional | 02/08/1996SE |
| K954627 | Ectra II Ligament Release SystemHRX · Traditional | 12/18/1995SN |
| K954989 | Dyonics Disposable Endoscopic Surgery BladesERL · Traditional | 11/27/1995SE |
| K953695 | Dyonics Disposable Arthroscopic BladesHRX · Traditional | 09/15/1995SE |
| K953387 | Ectra Ligament Release SystemHRX · Traditional | 08/09/1995SE |
| K945182 | Dyonics Fixation ScrewsHWC · Traditional | 01/24/1995SN |
| K934299 | Dyonics Disposable Arthroscopic Surgery Blades ModificationHRX · Traditional | 02/14/1994SE |
| K920267 | Dyonics Arthroscopic KitLRO · Traditional | 03/23/1993SEKD |
| K922176 | Intelijet Suction SupplyBTA · Traditional | 11/18/1992SE |
| K914963 | Smith & Nephew Dyonics TMJ Arthroscopy Inflow SetHRX · Traditional | 06/04/1992SE |
Questions and answers
When was Smith & Nephew Dyonics Inc. Electronic Endoscope cleared by the FDA?
Smith & Nephew Dyonics Inc. Electronic Endoscope (K936071) received a 510(k) decision of Substantially Equivalent on August 19, 1994, 242 days after the submission was received.
What is the product code of K936071?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.