INTRAOCULAR FORCEPS & SCISSORS— 510(k) K854869

Name: FDA 510(k) clearance K854869
Creator: U.S. Food and Drug Administration
Published: 1986-03-05

Substantially Equivalent

Mira, Inc.

FDA 510(k) clearance K854869 for INTRAOCULAR FORCEPS & SCISSORS, Substantially Equivalent on 1986-03-05. Applicant: Mira, Inc.. Device class: 1.

Clearance details

Applicant: Mira, Inc.
Product code: Code HNR
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1985-12-04
Decision date: 1986-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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K022835 — STEPHENS DISPOSABLE FORCEPS2002-11-01
K895434 — ALCON FOLDING FORCEPS1989-12-04
K891487 — SOFT LENS FOLDING BLOCK1989-08-15
K893199 — PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR1989-06-16
K885230 — MCDONALD FOLDING FORCEPS1989-05-17

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K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS1996-06-05
K941495 — RETURN PATH DIATHERMY HANDLE1994-07-15
K933527 — MODIFICATION OF ANTERIOR SEGMENT ELECTRODES1994-01-25
K923629 — OPHTHALMIC TRICHIASIS PROBE1992-10-19

Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.