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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

United States Surgical, A Division of Tyco Healthc · Predicate Candidate Screening

218 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

70 daysmedian FDA review time
231 days90th percentile
218clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERUnited States Surgical, A Division of Tyco Healthc2007-11-211840
K071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORUnited States Surgical, A Division of Tyco Healthc2007-09-28780
K061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIERUnited States Surgical, A Division of Tyco Healthc2006-11-021770
K062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSUnited States Surgical, A Division of Tyco Healthc2006-10-23280
K062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEUnited States Surgical, A Division of Tyco Healthc2006-09-01230
K061095AUTO SUTUR ENDO GIA STAPLERSUnited States Surgical, A Division of Tyco Healthc2006-05-31420
K050947MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTUREUnited States Surgical, A Division of Tyco Healthc2005-06-01472
K042412MODIFIED SPACEMAKER SYSTEMUnited States Surgical, A Division of Tyco Healthc2004-09-24170
K040594HERCULON SOFT TISSUE REATTACHMENT SYSTEMUnited States Surgical, A Division of Tyco Healthc2004-03-31230
K032696AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUUnited States Surgical, A Division of Tyco Healthc2003-12-01900
K032586CAPROSYN ABSORBABLE SUTUREUnited States Surgical, A Division of Tyco Healthc2003-11-17870
K024275AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLERUnited States Surgical, A Division of Tyco Healthc2003-03-14810
K020804AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLERUnited States Surgical, A Division of Tyco Healthc2002-11-192520
K020134SPIRAL RADIUS 90-D RODDING SYSTEMUnited States Surgical, A Division of Tyco Healthc2002-04-15900
K013671L-25 ABSORBABLE SURIGCAL SUTUREUnited States Surgical, A Division of Tyco Healthc2002-01-08630
K013860AUTO SUTURE SURGICAL STAPLESUnited States Surgical, A Division of Tyco Healthc2001-12-19288
K013890SURGICAL DYNAMICS MENISCAL STAPLEUnited States Surgical, A Division of Tyco Healthc2001-12-11180
K012539VERASTEPUnited States Surgical, A Division of Tyco Healthc2001-09-06300
K012273SPIRAL RADIUS 90-D SST SYSTEMUnited States Surgical, A Division of Tyco Healthc2001-08-15270
K003709SURGICAL DYNAMICS MESH CAGE SYSTEMUnited States Surgical, A Division of Tyco Healthc2001-07-182290
K010035IVS TUNNELLERUnited States Surgical, A Division of Tyco Healthc2001-04-04900
K001895AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLERUnited States Surgical, A Division of Tyco Healthc2000-12-081700
K002008SURGICAL DYNAMICS SPINAL RETRACTORUnited States Surgical, A Division of Tyco Healthc2000-08-16440
K001450AUTO SUTURE MICRO SURGICLIP CLIP APPLIERUnited States Surgical, A Division of Tyco Healthc2000-07-18710
K000037MONOFILAMENT BIOSYN SUTUREUnited States Surgical, A Division of Tyco Healthc2000-03-308427
K000009SPIRAL RADIUS RODDING SYSTEMUnited States Surgical, A Division of Tyco Healthc2000-03-10670
K992784NEXT GENERATION RODDING SYSTEMUnited States Surgical, A Division of Tyco Healthc1999-10-27690
K993055DEXIDE BIPOLAR FORCEPS II** DEVICEUnited States Surgical, A Division of Tyco Healthc1999-10-05220
K991859DEXIDE BIPOLAR FORCEPS II ** DEVICEUnited States Surgical, A Division of Tyco Healthc1999-06-23220
K983296AUTO SUTURE ABBI SYSTEMUnited States Surgical, A Division of Tyco Healthc1999-06-042560
K990951MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTUREUnited States Surgical, A Division of Tyco Healthc1999-04-01100
K990952NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUUnited States Surgical, A Division of Tyco Healthc1999-04-01102
K983400AUTO SUTURE SITE MARKER CLIPUnited States Surgical, A Division of Tyco Healthc1999-02-101350
K984438MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGEUnited States Surgical, A Division of Tyco Healthc1999-01-07240
K984342ANTERIOR CERVICAL PLATING SYSTEMUnited States Surgical, A Division of Tyco Healthc1998-12-30260
K983899THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)United States Surgical, A Division of Tyco Healthc1998-12-22490
K983904ROGOZINSKI SPINAL ROD SYSTEMUnited States Surgical, A Division of Tyco Healthc1998-12-22490
K983293AUTO SUTURE LAPAROSCOPES DEVICEUnited States Surgical, A Division of Tyco Healthc1998-12-16860
K982575MESH, SURGICAL, POLYMERICUnited States Surgical, A Division of Tyco Healthc1998-11-061050
K983197SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AUUnited States Surgical, A Division of Tyco Healthc1998-10-26450
K981935POLYSORB SUTUREUnited States Surgical, A Division of Tyco Healthc1998-06-25230
K980862TITANIUM SPINAL ROD SYSTEMUnited States Surgical, A Division of Tyco Healthc1998-05-20760
K981128SOFSILK SUTUREUnited States Surgical, A Division of Tyco Healthc1998-05-114213
K972911AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIERUnited States Surgical, A Division of Tyco Healthc1998-04-252610
K980124SOFSILK SUTUREUnited States Surgical, A Division of Tyco Healthc1998-03-27720
K974734AURORA TITANIUM SPINAL ROD SYSTEMUnited States Surgical, A Division of Tyco Healthc1998-03-10820
K974213AURORA TITANIUM SPINAL ROD SYSTEMUnited States Surgical, A Division of Tyco Healthc1998-02-04860
K973496THE AUTO SUTURE* MIBB** SYSTEMUnited States Surgical, A Division of Tyco Healthc1997-12-01770
K965228FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUEUnited States Surgical, A Division of Tyco Healthc1997-11-103140
K973281THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*United States Surgical, A Division of Tyco Healthc1997-11-03620

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda