ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)— 510(k) K970873

Name: FDA 510(k) clearance K970873
Creator: U.S. Food and Drug Administration
Published: 1997-05-20

Substantially Equivalent

American Medical Devices, Inc.

FDA 510(k) clearance K970873 for ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.), Substantially Equivalent on 1997-05-20. Applicant: American Medical Devices, Inc.. Device class: 1.

Clearance details

Applicant: American Medical Devices, Inc.
Product code: Code HMX
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1997-03-10
Decision date: 1997-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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K943932 — STERISEAL OPHTHALMIC CANNULA1995-01-18
K942403 — INFUSION CANNULA1994-08-17
K934844 — INTER TIP T1994-04-19

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K970882 — ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)1997-06-24
K970875 — ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)1997-05-20
K970878 — ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT1997-05-06

Adverse events under product code HMX

product code HMX

Other: 1
Total: 1

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.