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)

MANUAL SURGICAL INSTRUMENTS

K-Number: K921925 · 1993-05-26

Applicant3M Health Care, Ltd.
Decision Date1993-05-26
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANUAL SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Ltd.. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K921925. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL SURGICAL INSTRUMENTS?

MANUAL SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is 3M Health Care, Ltd.. The 510(k) number is K921925.

When did MANUAL SURGICAL INSTRUMENTS receive FDA 510(k) clearance?

MANUAL SURGICAL INSTRUMENTS received FDA 510(k) clearance on 1993-05-26, under 510(k) number K921925.

Who is the listed applicant for MANUAL SURGICAL INSTRUMENTS?

The FDA 510(k) record lists 3M Health Care, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL SURGICAL INSTRUMENTS?

The FDA product code for MANUAL SURGICAL INSTRUMENTS is GCJ.

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 3M Health Care, 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.

K953904SARNS 9000 UNIVERSAL ROLLER PUMPK926364ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129XK941534MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEMK941748STERI-VAC GAS STERILIZER MODEL 8XLK9306813M PREVENTION FABRIC SURGICAL GOWN #78XXK9323073M MAXI-DRIVER II DBATTERY POWERED SYSTEM

View all 49 devices →

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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.

↑