PRISMA DISPOSABLE MVR/STILETTO BLADE— 510(k) K874979

Name: FDA 510(k) clearance K874979
Creator: U.S. Food and Drug Administration
Published: 1988-04-13

Substantially Equivalent

Advanced Surgical Products, Inc.

FDA 510(k) clearance K874979 for PRISMA DISPOSABLE MVR/STILETTO BLADE, Substantially Equivalent on 1988-04-13. Applicant: Advanced Surgical Products, Inc.. Device class: 1.

Clearance details

Applicant: Advanced Surgical Products, Inc.
Product code: Code HNN
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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K881669 — MVR/STILETTO BLADE 20GA. - P/N 19001988-05-13
K874057 — OPHTHALMIC TIP & BLADE SCALPELS1987-12-23

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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 HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

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.