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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Davis & Geck, Inc. — Predicate Candidate Screening

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

73 daysmedian FDA review time
316 days90th percentile
45clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K982853SILK SUTUREDavis & Geck, Inc.1999-04-302600
K981582SURGILON, DERMALON, & OPHTHALONDavis & Geck, Inc.1998-07-13709
K974015ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PDavis & Geck, Inc.1998-05-182080
K980610DEXON RAPID (DEXON R)Davis & Geck, Inc.1998-05-18900
K980062MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DDavis & Geck, Inc.1998-03-20720
K973409KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPSDavis & Geck, Inc.1998-02-271710
K970857ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE Davis & Geck, Inc.1997-11-052400
K972139ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTIONDavis & Geck, Inc.1997-09-03890
K972566DEXON VIOLETDavis & Geck, Inc.1997-08-14360
K962971POLYPROPYLENE MESH (VARIOUS SIZES)Davis & Geck, Inc.1996-09-16470
K955722FLEXON TEMPORARY CARDIAC PACER LEADDavis & Geck, Inc.1996-03-15880
K955723STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)Davis & Geck, Inc.1996-02-27710
K953908DAVIS & GECK LIGATING CLIP REMOVERDavis & Geck, Inc.1995-11-301010
K953289TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGETDavis & Geck, Inc.1995-08-21380
K953425POLYETHYLENE TEREPHTHALATE (PET) PLEDGETDavis & Geck, Inc.1995-08-21310
K951352DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTUREDavis & Geck, Inc.1995-06-05730
K945701SURGILENE(R) SUTURESDavis & Geck, Inc.1995-01-24760
K930254DAVIS+GECK REUSABLE TRTOCARSDavis & Geck, Inc.1994-03-244290
K930588DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACIDDavis & Geck, Inc.1994-01-073370
K930591TI-CRON AND DACRON SUTURESDavis & Geck, Inc.1993-12-173166
K930587SURGILENE POLYPROPYLENE SUTUREDavis & Geck, Inc.1993-12-173160
K930586DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUTDavis & Geck, Inc.1993-12-173160
K930589PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTURDavis & Geck, Inc.1993-12-173160
K930590SILK SUTURESDavis & Geck, Inc.1993-12-173160
K925602DAVIS+GECK ABSORBABLE LIGATING DEVICEDavis & Geck, Inc.1993-07-082450
K920293DAVIS AND GECK HANDHELD INST. STERILIZATION TRAYDavis & Geck, Inc.1992-04-21900
K914365DEXON DISSECTING SPONGEDavis & Geck, Inc.1991-10-23220
K912556DAVIS AND GECK LAPRO-LOOP LIGATURE CARRIERDavis & Geck, Inc.1991-09-09900
K913411DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RINGDavis & Geck, Inc.1991-09-06370
K912319DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIERDavis & Geck, Inc.1991-08-22900
K900486APPOSE UNITY STERILE DISPOSABLE SKIN STAPLERDavis & Geck, Inc.1990-04-20780
K890902BIOFIX* BIODEGRADABLE FIXATION RODDavis & Geck, Inc.1989-11-032540
K894685DAVIS+GECK VISADUCT KITDavis & Geck, Inc.1989-08-22280
K881484BIOFRAGMENTABLE BOWEL ANASTOMOSIS RINGDavis & Geck, Inc.1988-05-04260
K863752VALTRAC (BAR) REMOVER DEVICEDavis & Geck, Inc.1986-10-24290
K855139FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENTDavis & Geck, Inc.1986-02-26650
K851452VALTRAC PURSESTING DEVICEDavis & Geck, Inc.1985-06-12620
K844417APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASEDavis & Geck, Inc.1984-12-17320
K843336AUTOMATIC MULTICLIP DISPOS. LIGATINGDavis & Geck, Inc.1984-10-31650
K840177APPOSE ULE STERILE DISPOS. SKIN STAPDavis & Geck, Inc.1984-03-05480
K840178APPOSE DISPOS. SKIN STAPLER W/AUTODavis & Geck, Inc.1984-03-05480
K830889DEXON 'S' POLYGLYCOLIC ACID MESHDavis & Geck, Inc.1983-05-09490
K820999MULTICLIP DISP. LIGATING CLIP DEVICEDavis & Geck, Inc.1982-05-13350
K811191DAVIS & GECK NEEDLE/SHARPS COUNTERDavis & Geck, Inc.1981-05-27270
K811030APPOSE SKIN STAPLERDavis & Geck, Inc.1981-05-27410

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