FDA 510(k)

NONABSORBABLE SILK SURGICAL SUTURE

K-Number: K904478 · 1990-11-14

ApplicantUnited States Surgical, A Division of Tyco Healthc

Decision Date1990-11-14

Product CodeGAP

Advisory CommitteeSU

DecisionSubstantially Equivalent for Some Indications

Device Summary

NONABSORBABLE SILK SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1990-11-14 under 510(k) number K904478. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NONABSORBABLE SILK SURGICAL SUTURE?

NONABSORBABLE SILK SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 1990-11-14. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K904478.

When did NONABSORBABLE SILK SURGICAL SUTURE receive FDA 510(k) clearance?

NONABSORBABLE SILK SURGICAL SUTURE received FDA 510(k) clearance on 1990-11-14, under 510(k) number K904478.

Who is the listed applicant for NONABSORBABLE SILK SURGICAL SUTURE?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NONABSORBABLE SILK SURGICAL SUTURE?

The FDA product code for NONABSORBABLE SILK SURGICAL SUTURE is GAP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing United States Surgical, A Division of Tyco Healthc as applicant

K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER K071920AUTOSUTURE ABSORBABLE TACK AND APPLICATOR K061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER K062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS K062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE K061095AUTO SUTUR ENDO GIA STAPLERS

View all 218 devices →

Related Devices (Code: GAP)

K241486Sofsilk™ Coated Braided Silk SutureCovidien K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.