PILOT TUBE REPAIR KIT— 510(k) K113644

Name: FDA 510(k) clearance K113644
Creator: U.S. Food and Drug Administration
Published: 2012-01-26

Substantially Equivalent

Instrumentation Industries, Inc.

FDA 510(k) clearance K113644 for PILOT TUBE REPAIR KIT, Substantially Equivalent on 2012-01-26. Applicant: Instrumentation Industries, Inc.. Device class: 2.

Clearance details

Applicant: Instrumentation Industries, Inc.
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2011-12-12
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Bethel Park, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSK

view all

K261499 — TrachFlush2026-08-13
K243562 — CuffGuard2025-08-12
K242642 — CuffTrek2025-03-07
K220854 — TrachCuff Cuff Controller2023-04-14
K221477 — AG100s2022-12-29

More clearances from Instrumentation Industries, Inc.

view all

K180510 — NS 120P-TRS Airway Pressure Gauge2019-05-01
K162753 — RTC 26-C Inline Aerosol Adapter2017-02-28
K102127 — ENDOTRACHEAL TUBE CHANGERS2010-08-27
K101857 — RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V2010-07-22
K091111 — RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC2009-12-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.