UNI-SITE— 510(k) K953018

Name: FDA 510(k) clearance K953018
Creator: U.S. Food and Drug Administration
Published: 1995-09-08

Substantially Equivalent

Ttl Medical

FDA 510(k) clearance K953018 for UNI-SITE, Substantially Equivalent on 1995-09-08. Applicant: Ttl Medical. Device class: Unclassified.

Clearance details

Applicant: Ttl Medical
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1995-06-29
Decision date: 1995-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MGP

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K012995 — COLLATEK SHEET2001-10-25
K012997 — COLLATEK FOAM2001-10-25
K001508 — LASERSKIN DRESSING2001-07-25
K990079 — FASTSEAL CHEST WOUND DRESSING1999-12-23
K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

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K952702 — DERMA SEAL1995-06-28

Adverse events under product code MGP

product code MGP

Other: 1
Total: 1

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.