FDA 510(k)

STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000

K-Number: K071482 · 2007-12-20

Decision Date2007-12-20

Product CodeGXD

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 is the device name listed in this FDA 510(k) record. The listed applicant is Synergetics, Inc.. It received FDA 510(k) clearance on 2007-12-20 under 510(k) number K071482. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000?

STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 is a medical device that received FDA 510(k) clearance on 2007-12-20. The listed applicant is Synergetics, Inc.. The 510(k) number is K071482.

When did STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 receive FDA 510(k) clearance?

STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 received FDA 510(k) clearance on 2007-12-20, under 510(k) number K071482.

Who is the listed applicant for STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000?

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

What is the FDA product code for STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000?

The FDA product code for STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 is GXD.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Synergetics, Inc. as applicant

K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS K121675VERSAVIT K113857SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS K091441SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET K063489STRYKER INTRADISCAL RF GENERATOR

View all 16 devices →

Related Devices (Code: GXD)

K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)Boston Scientific Neuromodulation Corporation K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc.K232632Racz Neurostat RF GeneratorEpimed International K231675OneRF Ablation SystemNeuroone Medical Technologies Corp.K220122APEX 6Rf Innovations, Inc.K203293Abbott Medical Grounding Pad, model RF-DGP-ISABBOTT 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.