NONABSORBABLE NYLON SURGICAL SUTURE*— 510(k) K900531

Clearance details

Applicant

United States Surgical, A Division of Tyco Healthc

Product code

Code GAR

Device class

Class 2

Regulation

21 CFR 878.5020

Advisory panel

General, Plastic Surgery

Date received

1990-02-05

Decision date

1990-07-05

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Norwalk, CT, US

• 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

• K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER2007-11-21
• K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR2007-09-28
• K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER2006-11-02
• K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS2006-10-23
• K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE2006-09-01

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 →

• Z-1173-2023 — Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12Class II·Ongoing·Covidien, LP·20221202
• Z-1174-2023 — Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSOF* 1 BLK 100CM GCC90X12 CN-830-L MONOSOF* 1 BLK 150CM LP GS25 N-2781K MONOSOF* 5-0 BLK 45CM SS24 DAX12 SN-1647 MONOSOF* 7-0 BLK 45CM P16 X36 SN-1647G MONOSOF* 7-0 BLK 45CM P16 X12 SN-247 MONOSOF* 3-0 BLK 90CM C23 X36 SN-3686 MONOSOF* 7-0 BLK 45CM P10 X12 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 SN-3697 MONOSOF* 6-0 BLK 45CM P10 X12 SN-3965 MONOSOF* 5-0 BLK 45CM PC11 X12 SN-5660G MONOSOF* 6-0 BLK 45CM P24 X12 SN-5665G MONOSOF* 6-0 BLK 45CM P12 X12 SN-5690G MONOSOF* 5-0 CLR 45CM P13 X12 SN-5691 MONOSOF* 4-0 CLR 45CM P13 X36 SN-5694 MONOSOF* 4-0 BLK 45CM P11 X36 SN-5696 MONOSOF* 6-0 BLK 45CM P13 X36 SN-5697 MONOSOF* 6-0 BLK 45CM P10 X36 SN-5767G MONOSOF* 6-0 BLK 45CM P11 X12 SN-630 MONOSOF* 4-0 BLK 75CM C22 X36 SN-643 MONOSOF* 5-0 BLK 75CM C13 X36 SN-667G MONOSOF* 6-0 BLK 45CM C1 X12 SN-694 MONOSOF* 2-0 BLK 90CM C18 X36 SN-871 MONOSOF* 5-0 BLK 45CM C1 X36 SN-872 MONOSOF* 4-0 BLK 45CM C1 X36 SUT GNJ-283 MONOSOF 2/0 BLK ST DA 90CM SUT N-59 MONOSOF 2-0 BLK 6X45CM PCTClass II·Ongoing·Covidien, LP·20221202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K900531.