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FDA 510(k)

SAW BLADE

K-Number: K933298 · 1993-08-09

ApplicantOmega Surgical Instruments, Inc.
Decision Date1993-08-09
Product CodeGFA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAW BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Omega Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1993-08-09 under 510(k) number K933298. The device is classified under product code GFA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAW BLADE?

SAW BLADE is a medical device that received FDA 510(k) clearance on 1993-08-09. The listed applicant is Omega Surgical Instruments, Inc.. The 510(k) number is K933298.

When did SAW BLADE receive FDA 510(k) clearance?

SAW BLADE received FDA 510(k) clearance on 1993-08-09, under 510(k) number K933298.

Who is the listed applicant for SAW BLADE?

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

What is the FDA product code for SAW BLADE?

The FDA product code for SAW BLADE is GFA.

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 Omega Surgical Instruments, 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.

K941434K-WIRES AND STEINMANN PINSK933595BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Related Devices (Code: GFA)

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.

K971978GRAFT HARVESTING SAWBLADESWrightmedicaltechnologyincK954483STRYKER SAGITTAL SAW ATTACHMENTStryker InstrumentsK955229WRIGHT MEDICAL TECHNOLOGY SAWBLADESWrightmedicaltechnologyincK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSBoston Surgical Products, Inc.K950403SURGICAL SAW BLADESTransidyne General Corp.K940501RE-SHARPENABLE SAW BLADESAdven Medical

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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