OPPORTUNITY I.V. START KIT— 510(k) K971093

Name: FDA 510(k) clearance K971093
Creator: U.S. Food and Drug Administration
Published: 1997-09-16

Substantially Equivalent for Some Indications

Opportunity, Inc.

FDA 510(k) clearance K971093 for OPPORTUNITY I.V. START KIT, Substantially Equivalent for Some Indications on 1997-09-16. Applicant: Opportunity, Inc.. Device class: Unclassified.

Clearance details

Applicant: Opportunity, Inc.
Product code: Code MGP
Device class: Unclassified
Advisory panel: Unknown
Date received: 1997-03-24
Decision date: 1997-09-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Highland Park, IL, US

Download summary PDF View on FDA.gov ↗

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K971088 — OPPORTUNITY INCISION AND DRAINAGE TRAY1997-09-16
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K971090 — OPPORTUNITY DRESSING CHANGE TRAY1997-09-16
K971091 — OPPURTUNITY TRACHEOSTOMY CARE KIT1997-09-16
K971095 — OPPORTUNITY SUTURE REMOVAL KIT1997-09-16

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.