A4907 Lens Cleaning Sheath
FDA 510(k) K961860 · Olympus America, Inc.
510(k) numberK961860
Submission
- Device name
- A4907 Lens Cleaning Sheath
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- May 14, 1996
- Decision date
- August 29, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K111788 | Endoeye HD IIHET · Traditional | 01/13/2012SE |
| K081615 | Olympus Cea - Carcinoembryonic AntigenDHX · Traditional | 03/18/2009SE |
| K073490 | Olympus Igg ReagentCFN · Traditional | 02/11/2008SE |
| K073489 | Olympus Iga ReagentCFN · Traditional | 02/11/2008SE |
| K073487 | Olympus Igm ReagentCFN · Traditional | 02/11/2008SE |
| K062862 | Olympus Uric Acid Reagent, Model OSR6X98KNK · Traditional | 04/06/2007SE |
| K063804 | Olympus Triglyceride Test SystemCDT · Traditional | 03/23/2007SE |
| K061499 | OsferionMQV · Traditional | 01/26/2007SE |
| K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemJLW · Traditional | 11/29/2006SE |
| K061575 | Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117CJY · Traditional | 10/05/2006SE |
Questions and answers
When was A4907 Lens Cleaning Sheath cleared by the FDA?
A4907 Lens Cleaning Sheath (K961860) received a 510(k) decision of Substantially Equivalent on August 29, 1996, 107 days after the submission was received.
What is the product code of K961860?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.