Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STAINLESS STEEL SOFT SUTURE WIRE

K-Number: K990355 · 1999-07-08

ApplicantBregma International Trading Company , Ltd.
Decision Date1999-07-08
Product CodeLRN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STAINLESS STEEL SOFT SUTURE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Bregma International Trading Company , Ltd.. It received FDA 510(k) clearance on 1999-07-08 under 510(k) number K990355. The device is classified under product code LRN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAINLESS STEEL SOFT SUTURE WIRE?

STAINLESS STEEL SOFT SUTURE WIRE is a medical device that received FDA 510(k) clearance on 1999-07-08. The listed applicant is Bregma International Trading Company , Ltd.. The 510(k) number is K990355.

When did STAINLESS STEEL SOFT SUTURE WIRE receive FDA 510(k) clearance?

STAINLESS STEEL SOFT SUTURE WIRE received FDA 510(k) clearance on 1999-07-08, under 510(k) number K990355.

Who is the listed applicant for STAINLESS STEEL SOFT SUTURE WIRE?

The FDA 510(k) record lists Bregma International Trading Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAINLESS STEEL SOFT SUTURE WIRE?

The FDA product code for STAINLESS STEEL SOFT SUTURE WIRE is LRN.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bregma International Trading Company , Ltd. as applicant

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.

K990351BONE SCREWSK990353STAINLESS STEEL FIXATION PINS

Related Devices (Code: LRN)

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.

K002755NON-ABSORBING STERNATOMY MONOFILAMENT SUTURET. Korossurgical Instruments Corp.K971682J-FX CERCLAGE SYSTEMJohnson & Johnson Professionals, Inc.K952783OXBORO-MEDICAL PIN COVERSOxboro Medical Intl., Inc.K942603ORTHOPAEDIC WIRESAcu Med, Inc.K900926TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS)Howmedica Corp.K892651SONGER WIRING SYSTEMDanek Medical, Inc.

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.

↑