TEKDYNE MICRO RETRACTOR— 510(k) K910975

Name: FDA 510(k) clearance K910975
Creator: U.S. Food and Drug Administration
Published: 1991-04-01

Substantially Equivalent

Tekdyne

FDA 510(k) clearance K910975 for TEKDYNE MICRO RETRACTOR, Substantially Equivalent on 1991-04-01. Applicant: Tekdyne. Device class: 1.

Clearance details

Applicant: Tekdyne
Product code: Code GAD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1991-03-07
Decision date: 1991-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quakertown, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAD

view all

K152538 — JRP Wound Spreader2016-04-13
K151104 — OTELO LL2016-01-06
K132645 — THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES2013-10-04
K071775 — DASH2007-08-07
K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR2005-04-26

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.