KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE— 510(k) K961977

Clearance details

Applicant

Kendall Healthcare Products Co. Div.Of Tyco Health

Product code

Code CBI

Device class

Class 2

Regulation

21 CFR 868.5740

Advisory panel

Anesthesiology

Date received

1996-05-20

Decision date

1996-07-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mansfield, MA, US

• K251950 — Endobronchial Blocker Tube (12 models)2026-03-20
• K253096 — Chartis Precision Catheter2026-02-13
• K232529 — Disposable Double Lumen Endobronchial Tube2024-05-13
• K232580 — Disposable Endobronchial Blocker Tube2023-12-14
• K222340 — Chartis Precision Catheter2022-12-01

• K973763 — KENDALL CURITY IODOFORM PACKING STRIP1997-12-31
• K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
• K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
• K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
• K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04

Death

4

Malfunction

594

Total

598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2367-2015 — HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.Class I·Terminated·Teleflex Medical·20150601

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961977.