DeviceClearance

DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE— 510(k) K990090

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K990090 for DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE, Substantially Equivalent on 1999-03-22. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant
Aesculap, Inc.
Product code
Code GAR
Device class
Class 2
Regulation
21 CFR 878.5020
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Aesculap, Inc.

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Adverse events under product code GAR

product code GAR
Injury
422
Malfunction
3,386
Other
4
Total
3,812

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 K990090

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 K990090.

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