DISPOSABLE WET FIELD ERASER— 510(k) K880925

Name: FDA 510(k) clearance K880925
Creator: U.S. Food and Drug Administration
Published: 1988-04-13

Substantially Equivalent

Advanced Surgical Products, Inc.

FDA 510(k) clearance K880925 for DISPOSABLE WET FIELD ERASER, Substantially Equivalent on 1988-04-13. Applicant: Advanced Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Surgical Products, Inc.
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 1988-03-04
Decision date: 1988-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterfield, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXI

view all

K253907 — Disposable Radiofrequency Cannula2026-04-16
K251802 — STAR RF Ablation System2026-02-13
K251243 — OneRF Trigeminal Nerve Radiofrequency Probes2025-08-15
K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)2025-05-27
K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more2025-05-15

More clearances from Advanced Surgical Products, Inc.

view all

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 GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.