ACHELASIA BALLOON DIALATOR— 510(k) K884715

Name: FDA 510(k) clearance K884715
Creator: U.S. Food and Drug Administration
Published: 1989-09-29

Substantially Equivalent

Primrose Medical, Inc.

FDA 510(k) clearance K884715 for ACHELASIA BALLOON DIALATOR, Substantially Equivalent on 1989-09-29. Applicant: Primrose Medical, Inc.. Device class: 2.

Clearance details

Applicant: Primrose Medical, Inc.
Product code: Code KNQ
Device class: Class 2
Regulation: 21 CFR 876.5365
Advisory panel: Gastroenterology, Urology
Date received: 1988-11-08
Decision date: 1989-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Primrose Medical, Inc.

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K884711 — URETHRAL AND URETERAL BALLOON DILATATORS1989-09-29
K884713 — COLONIC BALLOON DIALATORS1989-09-29
K884714 — BILIARY DIALATOR1989-09-29
K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)1989-09-08
K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORS1989-09-08

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.