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)

MULTITAK SUTURE SNAP SYSTEM

K-Number: K013177 · 2001-12-19

ApplicantBonutti Research, Inc.
Decision Date2001-12-19
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTITAK SUTURE SNAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bonutti Research, Inc.. It received FDA 510(k) clearance on 2001-12-19 under 510(k) number K013177. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTITAK SUTURE SNAP SYSTEM?

MULTITAK SUTURE SNAP SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-19. The listed applicant is Bonutti Research, Inc.. The 510(k) number is K013177.

When did MULTITAK SUTURE SNAP SYSTEM receive FDA 510(k) clearance?

MULTITAK SUTURE SNAP SYSTEM received FDA 510(k) clearance on 2001-12-19, under 510(k) number K013177.

Who is the listed applicant for MULTITAK SUTURE SNAP SYSTEM?

The FDA 510(k) record lists Bonutti Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTITAK SUTURE SNAP SYSTEM?

The FDA product code for MULTITAK SUTURE SNAP SYSTEM is GAM.

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 Bonutti Research, Inc. 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.

K161628JAS Pulse(TM) Ultrasonic TherapyK093078UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORSK090175UNITY BETA PLLA SYSTEMK082906UNITY BETA ANCHOR SYSTEMK062820UNITY ALPHA SYSTEMK060283TRANSET SYSTEM

View all 12 devices →

Related Devices (Code: GAM)

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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

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.

↑