DeviceClearance

FLEXTIP PLUS EPIDURAL CATHETER; FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET— 510(k) K140110

Substantially Equivalent

Teleflex, Inc.

FDA 510(k) clearance K140110 for FLEXTIP PLUS EPIDURAL CATHETER; FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET, Substantially Equivalent on 2015-03-27. Applicant: Teleflex, Inc.. Device class: 2.

Clearance details

Device name as filed
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
Applicant
Teleflex, Inc.
Product code
Code BSO
Device class
Class 2
Regulation
21 CFR 868.5120
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Reading, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BSO

product code BSO
Malfunction
688
Total
688

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

Recalls naming K140110

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140110.

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