ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP— 510(k) K010007

Name: FDA 510(k) clearance K010007
Creator: U.S. Food and Drug Administration
Published: 2001-02-22

Substantially Equivalent

Taut, Inc.

FDA 510(k) clearance K010007 for ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP, Substantially Equivalent on 2001-02-22. Applicant: Taut, Inc.. Device class: 2.

Clearance details

Applicant: Taut, Inc.
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2001-01-02
Decision date: 2001-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, IL, US

Download summary PDF View on FDA.gov ↗

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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
K992904 — MINI-PORT1999-10-05

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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 →

Recalls naming K010007

K-number listed on FDA's recall record

Z-1279-2014 — 5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.Class II·Terminated·Teleflex Medical·20140311
Z-1284-2014 — 5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.Class II·Terminated·Teleflex Medical·20140311
Z-1326-2014 — 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.Class II·Terminated·Teleflex Medical·20140311

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010007.

Data sourced from openFDA. This site is unofficial and independent of the FDA.