MINI-PORT— 510(k) K992904

Name: FDA 510(k) clearance K992904
Creator: U.S. Food and Drug Administration
Published: 1999-10-05

Substantially Equivalent

Taut, Inc.

FDA 510(k) clearance K992904 for MINI-PORT, Substantially Equivalent on 1999-10-05. Applicant: Taut, Inc.. Device class: 1.

Clearance details

Applicant: Taut, Inc.
Product code: Code GBW
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1999-08-30
Decision date: 1999-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, IL, US

Download summary PDF View on FDA.gov ↗

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K992907 — INTRADUCER1999-10-05
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K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN1996-08-08
K960426 — MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER1996-03-21
K942709 — MEDIASTINAL SILICONE DRAINS1996-01-04

More clearances from Taut, Inc.

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K023261 — ADAPT BALLOON OPEN ACCESS PORT, MODEL 412442002-12-13
K021731 — ADAPT OPEN ACCESS PORT, MODEL 412332002-08-08
K011018 — TAUT BALLOON CATHETER, MODEL 506402001-06-22
K003703 — TAUT-INSUFFLATION NEEDLE2001-02-22
K010007 — ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP2001-02-22

Adverse events under product code GBW

product code GBW

Death: 6
Total: 6

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.