Medical Device Manufacturer · US , Chesterfield , MO

Synergetics, Inc.

16 submissions · 16 cleared · Since 1992
16
Total
16
Cleared
0
Denied

Synergetics, Inc. — FDA 510(k) Submissions

Synergetics, Inc. has submitted 16 FDA 510(k) premarket notifications since 1992, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Instrument, Ultrasonic Surgical, Endoilluminator, Generator, Lesion, Radiofrequency, Instrument, Vitreous Aspiration And Cutting, Ac-powered . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS
K121426 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2012 57d
VERSAVIT
K121675 · HQE Instrument, Vitreous... · Ophthalmic
Jun 2012 15d
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
K113857 · HQB Photocoagulator And... · Ophthalmic
Apr 2012 115d
DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
K110924 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2011 247d
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
K091441 · FRN Pump, Infusion · General Hospital
Oct 2009 168d
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
K071482 · GXD Generator, Lesion,... · Neurology
Dec 2007 204d
STRYKER INTRADISCAL RF GENERATOR
K063489 · GXD Generator, Lesion,... · Neurology
May 2007 187d
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K032598 · MPA Endoilluminator · Ophthalmic
Nov 2003 91d
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
K020220 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Aug 2002 213d
SONOTOME ULTRASONIC ASPIRATOR TIPS
K010637 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Apr 2001 46d
SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01
K990568 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 1999 80d
VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010
K982212 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 1998 162d
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K964005 · MPA Endoilluminator · Ophthalmic
Jun 1997 275d
OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
K932668 · HQE Instrument, Vitreous... · Ophthalmic
Feb 1994 266d
OPHTHALMIC PHARCO NEEDLE
K923725 · HQC Unit, Phacofragmentation · Ophthalmic
Mar 1993 234d
OPHTHALMIC VISCOINJECTOR DRIVE
K923326 · KZE Injector, Fluid,... · General Hospital
Sep 1992 85d
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