ACCUFLATE— 510(k) K924273

Name: FDA 510(k) clearance K924273
Creator: U.S. Food and Drug Administration
Published: 1993-01-12

Substantially Equivalent

Instrumed, Inc.

FDA 510(k) clearance K924273 for ACCUFLATE, Substantially Equivalent on 1993-01-12. Applicant: Instrumed, Inc.. Device class: 1.

Clearance details

Applicant: Instrumed, Inc.
Product code: Code KCY
Device class: Class 1
Regulation: 21 CFR 878.5910
Advisory panel: General, Plastic Surgery
Date received: 1992-08-24
Decision date: 1993-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Instrumed, Inc.

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K952038 — CLEAN-CUFF1995-07-11
K940615 — ACCUTEST1995-05-19
K924373 — ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP1992-11-25
K910512 — ACCUFLATE1991-02-19
K890014 — DISPOSABLE COLOR-CUFFS1989-01-24

Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.