ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE— 510(k) K091900

Clearance details

Applicant

Covidien Lp, Formerly Registered AS United States

Product code

Code GDW

Device class

Class 2

Regulation

21 CFR 878.4750

Advisory panel

General, Plastic Surgery

Date received

2009-06-25

Decision date

2009-07-16

Decision

Substantially Equivalent

Clearance type

Special

Location

North Haven, CT, US

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• K091869 — SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS2009-09-01
• K083519 — AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS2009-04-10
• K090419 — SILS STITCH ENDOSCOPIC SUTURING DEVICE2009-03-09
• K082619 — SILS PORT, MODELS SILSPT5, SILSPT122008-11-07
• K082659 — MODIFIED ENDO STICH2008-09-19

Death

450

Injury

12,684

Malfunction

68,730

Other

6

Total

81,870

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 →