HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH
FDA 510(k) K080948 · Olympus Medical Systems Corporation
510(k) numberK080948
Submission
- Device name
- HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH
- Applicant
- Olympus Medical Systems Corporation
Center Valley, PA, US - Received
- April 3, 2008
- Decision date
- September 26, 2008
- 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
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| 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 |
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| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | 09/10/2026SE |
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | 08/27/2026SE |
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | 08/27/2026SE |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | 07/31/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | 07/01/2026SE |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LBFET · Traditional | 06/24/2026SE |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | 05/21/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | 04/23/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | 03/20/2026SE |
Questions and answers
When was HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH cleared by the FDA?
HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH (K080948) received a 510(k) decision of Substantially Equivalent on September 26, 2008, 176 days after the submission was received.
What is the product code of K080948?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.