VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE— 510(k) K902010

Name: FDA 510(k) clearance K902010
Creator: U.S. Food and Drug Administration
Published: 1990-06-20

Substantially Equivalent

Visitec Co.

FDA 510(k) clearance K902010 for VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE, Substantially Equivalent on 1990-06-20. Applicant: Visitec Co.. Device class: 1.

Clearance details

Applicant: Visitec Co.
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1990-05-03
Decision date: 1990-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

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K952606 — TARGETT PATCH1995-12-21

More clearances from Visitec Co.

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K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}1995-10-12
K945114 — VISITEC SCLERAL PLUG1995-02-23
K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE1995-02-14
K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS1995-01-17
K942234 — VISITEC PRECISE-POINT1994-07-12

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.