STERILE DISSECTOR SPONGES-X-RAY DETECT— 510(k) K812707

Name: FDA 510(k) clearance K812707
Creator: U.S. Food and Drug Administration
Published: 1981-11-02

Substantially Equivalent

Medspec Corp.

FDA 510(k) clearance K812707 for STERILE DISSECTOR SPONGES-X-RAY DETECT, Substantially Equivalent on 1981-11-02. Applicant: Medspec Corp.. Device class: 1.

Clearance details

Applicant: Medspec Corp.
Product code: Code GDY
Device class: Class 1
Regulation: 21 CFR 878.4450
Advisory panel: General, Plastic Surgery
Date received: 1981-09-24
Decision date: 1981-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K955322 — PROTEC X-RAY DETECTABLE GAUZE SPONGE1995-12-19
K953830 — KENSORB1995-10-03

More clearances from Medspec Corp.

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K813012 — STERILE BASIN SETS1981-11-06
K812710 — STERILE LAPAROTOMY SPONGES-X-RAY DETECT1981-11-02
K812711 — STERILE GAUZE PADS 12PLY1981-11-02
K812709 — STERILE DENTAL ROLL1981-10-23
K810071 — STERILE SILICONE TUBING1981-02-12

Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.