RETRACTOR— 510(k) K941448

Name: FDA 510(k) clearance K941448
Creator: U.S. Food and Drug Administration
Published: 1994-04-15

Substantially Equivalent

Technovations

FDA 510(k) clearance K941448 for RETRACTOR, Substantially Equivalent on 1994-04-15. Applicant: Technovations. Device class: 1.

Clearance details

Applicant: Technovations
Product code: Code GAD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1994-03-24
Decision date: 1994-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy, UT, US

Download summary PDF View on FDA.gov ↗

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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.