STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE— 510(k) K903029

Name: FDA 510(k) clearance K903029
Creator: U.S. Food and Drug Administration
Published: 1990-10-25

Substantially Equivalent

Look, Inc.

FDA 510(k) clearance K903029 for STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE, Substantially Equivalent on 1990-10-25. Applicant: Look, Inc.. Device class: 2.

Clearance details

Applicant: Look, Inc.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 1990-07-10
Decision date: 1990-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAR

view all

K261484 — Tissue Approximation System2026-06-03
K220980 — Tissue Approximation System (TAS)2023-07-05
K212888 — Golnit Nylon Monofilament Suture2022-03-31
K212603 — Non Absorbable Surgical Nylon Suture2021-12-22
K192420 — Crownjun Nylon Suture2020-05-29

More clearances from Look, Inc.

view all

K943949 — POLYVIOLENE SURGICL SUTURE1994-11-10
K933686 — LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE1993-12-23
K926586 — REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES1993-12-22
K926167 — POLYVIOLENE SUTURE-REVISED LABELING1993-12-17
K926168 — SILK SUTURES-REVISED LABELING1993-12-17

Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.