OPHTHALMIC CANNULA— 510(k) K881487

Name: FDA 510(k) clearance K881487
Creator: U.S. Food and Drug Administration
Published: 1988-04-29

Substantially Equivalent

Surgical Instrument, Inc.

FDA 510(k) clearance K881487 for OPHTHALMIC CANNULA, Substantially Equivalent on 1988-04-29. Applicant: Surgical Instrument, Inc.. Device class: 1.

Clearance details

Applicant: Surgical Instrument, Inc.
Product code: Code HMX
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1988-04-08
Decision date: 1988-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HMX

view all

K010305 — WEISS RETINAL CANNULA2001-05-02
K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES2000-05-09
K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)1997-05-20
K943932 — STERISEAL OPHTHALMIC CANNULA1995-01-18
K942403 — INFUSION CANNULA1994-08-17

More clearances from Surgical Instrument, Inc.

view all

K930607 — GRIPPER1994-02-15
K923667 — IRRIGATION/SUCTION PROBE1993-04-23

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.