DeviceClearance

INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES— 510(k) K090159

Substantially Equivalent

Incisive Surgical, Inc.

FDA 510(k) clearance K090159 for INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES, Substantially Equivalent on 2009-02-06. Applicant: Incisive Surgical, Inc.. Device class: 2.

Clearance details

Applicant
Incisive Surgical, Inc.
Product code
Code GDW
Device class
Class 2
Regulation
21 CFR 878.4750
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

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More clearances from Incisive Surgical, Inc.

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Adverse events under product code GDW

product code GDW
Death
450
Injury
12,684
Malfunction
68,730
Other
6
Total
81,870

Source: openFDA MAUDE database, through . 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 K090159

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090159.

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