510(k) K151522

DEFENDO Bronchoscopy Suction Valve by Medivators, Inc. — Product Code KTI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 17, 2015
Date Received: June 5, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bronchoscope Accessory
Device Class: Class II
Regulation Number: 874.4680
Review Panel: EN
Submission Type

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 clearances by Medivators, Inc.

K231418 — ENDOGATOR Hybrid Irrigation Tubing (August 14, 2023)
K223040 — Endo SmartCap (March 1, 2023)
K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid (January 14, 2022)
K172677 — Advantage Plus Pass-Thru (December 19, 2017)
K162128 — Scope Buddy Plus Endoscope Flushing Aid (December 21, 2016)
K160846 — AmplifEYE (July 14, 2016)
K152394 — Rapicide PA High-Level Disinfectant Test Strips (March 11, 2016)
K133724 — MINNCARE HD (August 27, 2014)
K140753 — ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM (July 15, 2014)
K993042 — MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT (August 17, 2000)

Other clearances for product code KTI

K254040 — LungFlow Basket Catheter (March 12, 2026)
K251402 — LIA-1 Catheter (542-1) (December 19, 2025)
K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (October 8, 2025)
K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA (July 29, 2025)
K250263 — Disposable Grasping Forceps FG-52D/FG-54D (March 31, 2025)
K241679 — Disposable Cytology Brush (AF series) (March 4, 2025)
K231818 — METIC- Airway Balloon Catheter (November 15, 2023)
K230778 — EndoCore (September 25, 2023)
K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (May 11, 2023)
K222187 — Multistage Balloon Dilatation Catheter (March 1, 2023)