SMART DILATOR— 510(k) K082995

Name: FDA 510(k) clearance K082995
Creator: U.S. Food and Drug Administration
Published: 2009-02-06

Substantially Equivalent

Safestitch Medical

FDA 510(k) clearance K082995 for SMART DILATOR, Substantially Equivalent on 2009-02-06. Applicant: Safestitch Medical. Device class: 2.

Clearance details

Applicant: Safestitch Medical
Product code: Code KNQ
Device class: Class 2
Regulation: 21 CFR 876.5365
Advisory panel: Gastroenterology, Urology
Date received: 2008-10-08
Decision date: 2009-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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K122924 — CRE FIXED WIRE BALLON DILATION CATHETER2012-10-24
K093236 — ETHICON ENDO-SURGERYOPTICAL DILATOR2009-11-10
K090183 — HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON2009-09-25
K061937 — COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON2006-12-01
K061787 — MAXFORCE TTS SINGLE-USE BALLOON DILATOR2006-09-21

Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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 →

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