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FDA 510(k)

MANI NEEDLE & SUTURE PACK

K-Number: K050150 · 2005-12-05

ApplicantMani, Inc.
Decision Date2005-12-05
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MANI NEEDLE & SUTURE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Mani, Inc.. It received FDA 510(k) clearance on 2005-12-05 under 510(k) number K050150. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANI NEEDLE & SUTURE PACK?

MANI NEEDLE & SUTURE PACK is a medical device that received FDA 510(k) clearance on 2005-12-05. The listed applicant is Mani, Inc.. The 510(k) number is K050150.

When did MANI NEEDLE & SUTURE PACK receive FDA 510(k) clearance?

MANI NEEDLE & SUTURE PACK received FDA 510(k) clearance on 2005-12-05, under 510(k) number K050150.

Who is the listed applicant for MANI NEEDLE & SUTURE PACK?

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

What is the FDA product code for MANI NEEDLE & SUTURE PACK?

The FDA product code for MANI NEEDLE & SUTURE PACK is GAT.

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 Mani, 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.

K053638MANI NEEDLE & SUTURE PACK (SILK)K053637MANI NEEDLE & SUTURE PACK (NYLON)K053636MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, 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.

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