PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA— 510(k) K874972

Name: FDA 510(k) clearance K874972
Creator: U.S. Food and Drug Administration
Published: 1988-04-13

Substantially Equivalent

Advanced Surgical Products, Inc.

FDA 510(k) clearance K874972 for PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA, Substantially Equivalent on 1988-04-13. Applicant: Advanced Surgical Products, Inc.. Device class: 1.

Clearance details

Applicant: Advanced Surgical Products, Inc.
Product code: Code HMX
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1987-12-02
Decision date: 1988-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterfield, MO, US

Download summary PDF View on FDA.gov ↗

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K030926 — FAST THROW STAINLESS STEEL SURGICAL SUTURE2003-07-21
K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR1990-01-22
K896754 — I/A HANDPIECE1990-01-11
K896305 — MULTI-USE I/A HANDPIECE1989-12-18
K884557 — ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE1989-05-12

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.