PeriView FLEX
FDA 510(k) K171232 · Olympus Surgical Technologies America
510(k) numberK171232
Submission
- Device name
- PeriView FLEX
- Applicant
- Olympus Surgical Technologies America
Southborough, MA, US - Received
- April 27, 2017
- Decision date
- September 21, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTI – Bronchoscope Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code KTI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…KTI · Traditional | Cook Ireland, Ltd. | 07/24/2026SE |
| K251478 | ClearTip TBNA TypeKTI · Traditional | Finemedix Co., Ltd. | 04/16/2026SE |
| K254040 | LungFlow Basket CatheterKTI · Traditional | Free Flow Medical, Inc. | 03/12/2026SE |
| K251402 | LIA-1 Catheter (542-1)KTI · Traditional | Leadoptik, Inc. | 12/19/2025SE |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01KTI · Special | Serpex Medical, Inc. | 10/08/2025SE |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)KTI · Traditional | Olympus Medical Systems Corporation | 07/29/2025SE |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54DKTI · Traditional | Olympus Medical Systems Corp. | 03/31/2025SE |
| K241679 | Disposable Cytology Brush (AF series)KTI · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 03/04/2025SE |
| K231818 | METIC- Airway Balloon CatheterKTI · Traditional | M/S Meril Life Sciences Pvt. , Ltd. | 11/15/2023SE |
| K230778 | EndoCoreKTI · Traditional | Praxis Medical, LLC | 09/25/2023SE |
More from Praxis Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | 07/24/2026SE |
| K242191 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Special | 08/23/2024SE |
| K212643 | POWERSEAL Curved Jaw Sealer and Divider, Double ActionGEI · Special | 09/27/2021SE |
| K193517 | ViziShot 2 FLEXKTI · Traditional | 03/18/2020SE |
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | 08/09/2019SE |
| K190164 | CleverLock Guidewire Locking Device and Biopsy CapODC · Traditional | 04/04/2019SE |
| K181193 | PeriView FLEXKTI · Special | 07/03/2018SE |
| K163469 | ViziShot 2 FLEXKTI · Traditional | 04/06/2017SE |
| K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation CatheterFGE · Traditional | 03/27/2015SE |
| K132181 | Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterEZN · Traditional | 10/21/2013SE |
Questions and answers
When was PeriView FLEX cleared by the FDA?
PeriView FLEX (K171232) received a 510(k) decision of Substantially Equivalent on September 21, 2017, 147 days after the submission was received.
What is the product code of K171232?
The FDA product code is KTI – Bronchoscope Accessory, a Class II (moderate risk) device regulated under 21 CFR 874.4680.