RETRACTOR, SURGICAL— 510(k) K852330

Name: FDA 510(k) clearance K852330
Creator: U.S. Food and Drug Administration
Published: 1985-06-27

Substantially Equivalent

Scholten Surgical Instruments, Inc.

FDA 510(k) clearance K852330 for RETRACTOR, SURGICAL, Substantially Equivalent on 1985-06-27. Applicant: Scholten Surgical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Scholten Surgical Instruments, Inc.
Product code: Code GAD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-05-31
Decision date: 1985-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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K072051 — NOVATOME, MODEL: SU101-502007-10-03
K900405 — SCHOLTEN FRAME1990-03-01
K852331 — SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC1986-08-01
K852119 — TEMPORARY PACEMAKER GROUND WIRE1985-09-15
K852120 — FORCEPS, BIOPSY(NON RIGID)1985-07-02

Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.