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510(k) K121426 · GEI Electrosurgical, Cutting & Coagulation & Accessories

AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS

Applicant	Synergetics, Inc., O' Fallon MO, US
Decision	Substantially Equivalent, Jul 10, 2012
Received	May 14, 2012
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K121426

Date	Firm and product	Code	Linked 510(k)
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010 Open, Classified	GEI	None listed
Nov 7, 2023	Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015 Open, Classified	GEI	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.