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Synergetics Inc

FDA Regulatory Profile

Synergetics Inc appears in FDA public data with 37 recalls — including 4 Class I (most serious) —, 18 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2252-2024, Class I) was initiated on Jun 12, 2024. Its most recent 510(k) clearance was granted on Oct 12, 2016.

Summary

Total Recalls
37 (4 Class I)
510(k) Clearances
18
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2252-2024Class IBAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injeJun 12, 2024
Z-2253-2024Class IBAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration of intravitreal injectiJun 12, 2024
Z-2251-2024Class IBAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)Jun 12, 2024
Z-2254-2024Class IBAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intraviJun 12, 2024
Z-0121-2017Class II25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SPAug 11, 2016
Z-0119-2017Class II25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rAug 11, 2016
Z-0122-2017Class II25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar doubleAug 11, 2016
Z-0120-2017Class II25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packageAug 11, 2016
Z-0898-2014Class II23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 uniDec 9, 2013
Z-0899-2014Class II25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 uniDec 9, 2013
Z-0891-2014Class IITwo-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7Dec 9, 2013
Z-0887-2014Class II27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. PacDec 9, 2013
Z-0876-2014Class II23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed Dec 9, 2013
Z-0878-2014Class II29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 unDec 9, 2013
Z-0879-2014Class II25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.2Dec 9, 2013
Z-0894-2014Class II23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed Dec 9, 2013
Z-0889-2014Class II23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Dec 9, 2013
Z-0885-2014Class II25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per Dec 9, 2013
Z-0893-2014Class IIWide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 Dec 9, 2013
Z-0881-2014Class II27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. PDec 9, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K160103Spetzler Malis Dual Illuminating Bipolar ForcepsOct 12, 2016
K143123Synergetics PHOTON EXFeb 24, 2015
K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSJul 10, 2012
K121675VERSAVITJun 21, 2012
K113857SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBEApr 23, 2012
K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPSDec 7, 2011
K091441SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SETOct 30, 2009
K071482STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000Dec 20, 2007
K063489STRYKER INTRADISCAL RF GENERATORMay 23, 2007
K032598SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCENov 24, 2003
K020220ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTEAug 23, 2002
K010637SONOTOME ULTRASONIC ASPIRATOR TIPSApr 20, 2001
K990568SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MOMay 14, 1999
K982212VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N30Dec 2, 1998
K964005SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCEJun 9, 1997
K932668OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVERFeb 23, 1994
K923725OPHTHALMIC PHARCO NEEDLEMar 18, 1993
K923326OPHTHALMIC VISCOINJECTOR DRIVESep 30, 1992

FDA data resources