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Data / Medical devices / Mexico / Surgical Specialties Mexico S DE RL DE CV

Surgical Specialties Mexico S DE RL DE CV: FDA-registered device maker in Tijuana Baja California, Mexico, 39 510(k) clearances and 1 PMA approval

Surgical Specialties Mexico S DE RL DE CV is registered with the FDA (registration 3010692967) in Tijuana Baja California, Mexico. It lists 23 device types. The FDA files 39 510(k) clearances and 1 PMA approval under its listings, the newest dated July 13, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Surgical Specialties Mexico S DE RL DE CV
FDA registration number
3010692967
Address
Corredor Tijuana - Rosarito 2000-24702 B Ejido Francisco Villa, Tijuana Baja California, Mexico, 22235
Owner or operator
Corza Medical Inc (9060279)
Roles
Contract manufacturer, Manufacturer
First device listed
June 26, 1992
Registered through
2026
Brand names listed
6S Vision, Arthrex® Tightrope, B. G. Sulzle, Edge Tec, FA PGA Sutures - Sharpoint, FSSB, Flow Controller, Focus and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Contract manufactureraccessdata.fda.gov
ArthroscopeHRX2Contract manufactureraccessdata.fda.gov
Blade, ScalpelGES1Manufactureraccessdata.fda.gov
Carrier, LigatureGEJ1Contract manufactureraccessdata.fda.gov
Device, Occlusion, UmbilicalFOD1Manufactureraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Contract manufactureraccessdata.fda.gov
Knife, OphthalmicHNN1Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
Needle, Neurosurgical SutureHAS1Manufactureraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Manufactureraccessdata.fda.gov
Needle, Suturing, ReusableGDL1Manufactureraccessdata.fda.gov
Needle, Tonsil SuturingKBR1Manufactureraccessdata.fda.gov
Plug, PunctumLZUUContract manufacturer, Manufactureraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Manufactureraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGAQ2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Contract manufacturer, Manufactureraccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Contract manufacturer, Manufactureraccessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneNBY2Contract manufacturer, Manufactureraccessdata.fda.gov
Wax, BoneMTJUManufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 13, 2016K160744LOOK PTFE SutureNBYSubstantially EquivalentSurgical Specialties Corporationaccessdata.fda.gov
September 10, 2015K151112Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignGAWSubstantially EquivalentAngiotechaccessdata.fda.gov
July 30, 2014K141778QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNGAMSubstantially EquivalentSurgical Specialties Corporationaccessdata.fda.gov
July 18, 2014K141625POLYSYN SURGICAL SUTUREGAMSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
July 11, 2014K141558QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICEGAMSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
February 28, 2014K140227MONODERM SURGICAL SUTUREGAMSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
August 23, 2013K132268QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNNEWSubstantially EquivalentSurgical Specialties Corporation Dba Angiotechaccessdata.fda.gov
May 16, 2013K131224SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSUREGAWSubstantially EquivalentSurgical Specialties Corp. Dba Angiotechaccessdata.fda.gov
February 28, 2013K130078QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNGAWSubstantially EquivalentSurgical Specialties Corp. Dba Angiotechaccessdata.fda.gov
January 2, 2013K123877QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNNEWSubstantially EquivalentSurgical Specialties Corp. Dba Angiotechaccessdata.fda.gov
December 21, 2012K123836QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNGAMSubstantially EquivalentSurgical Specialties Corp. Dba Angiotechaccessdata.fda.gov
November 20, 2012K123409QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNGAMSubstantially EquivalentSurgical Specialties Corp. Dba Angiotechaccessdata.fda.gov
October 22, 2012K122898QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNGAMSubstantially EquivalentSurgical Specialties Corp. Dba Angiotechaccessdata.fda.gov
July 13, 2012K120827QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)NEWSubstantially EquivalentAngiotechaccessdata.fda.gov
February 1, 2012K113744QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)NEWSubstantially EquivalentAngiotechaccessdata.fda.gov
April 23, 2008K080985QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)NEWSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
March 21, 2008K080680QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONENEWSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
August 3, 2007K072028QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERMGAMSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
May 9, 2007K063680SHARPOINT PDO (POLYDIOXANONE) SUTURESNEWSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
November 7, 2005K052437MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTUREGAMSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
September 26, 2005K052373QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTUREGAWSubstantially EquivalentQuill Medical, Inc.accessdata.fda.gov
August 4, 2005K051609QUILL SYNTHETIC ABSORBABLE BARBED SUTURENEWSubstantially EquivalentQuill Medical, Inc.accessdata.fda.gov
March 9, 2005K050292SHARPOINT LUKENS BONE WAXMTJSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
July 26, 2002K020882SHARPOINT ULTRAPLUG EXTENDED WEAR PLUGLZUSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
January 28, 2002K014021SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYEDGAMSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
May 11, 1998K980844SURGIDEV SILICONE PUNCTUM PLUGLZUSubstantially EquivalentAdvanced Vision Scienceaccessdata.fda.gov
February 12, 1997K965162LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.GAMSubstantially EquivalentLukens Medical Corp.accessdata.fda.gov
November 10, 1994K943949POLYVIOLENE SURGICL SUTUREGATSubstantially Equivalent for Some IndicationsLook, Inc.accessdata.fda.gov
January 7, 1994K930826SUTURE NONABSORBABLE - SILKGAPSubstantially EquivalentSurgical Specialties, Inc.accessdata.fda.gov
January 7, 1994K930825SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLESGAPSubstantially EquivalentSurgical Specialties, Inc.accessdata.fda.gov
December 23, 1993K933686LOOK INC. 316L STAINLESS STEEL SURGICAL SUTUREGAQSubstantially EquivalentLook, Inc.accessdata.fda.gov
December 24, 1990K904906SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USPGAWSubstantially EquivalentChathamborough Research Group, Inc.accessdata.fda.gov
October 25, 1990K903029STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTUREGARSubstantially EquivalentLook, Inc.accessdata.fda.gov
October 11, 1990K903584POLYPROPYLENE NONABSORBABLE SURGICAL SUTURESGAWSubstantially EquivalentLook, Inc.accessdata.fda.gov
May 31, 1990K896554GUT SUTURESGALSubstantially Equivalent for Some IndicationsLook, Inc.accessdata.fda.gov
March 28, 1990K897190LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANTLZUSubstantially EquivalentLook, Inc.accessdata.fda.gov
June 6, 1986K861947SURGICAL KNIFEEMFSubstantially EquivalentSharpoint, Inc.accessdata.fda.gov
August 10, 1982K822112OPHTHALMIC KNIFEHNNSubstantially EquivalentSharpoint, Inc.accessdata.fda.gov
September 24, 1979K791495LUKENS BONE WAX (GAMMA RADIATION)MTJSubstantially EquivalentLukens Corp.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
October 27, 1986N85143SUTURESGAP7August 31, 1988accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 24, 201675273Class IITerminatedBioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.accessdata.fda.gov

Compare with other makers

Updated July 13, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.