Atlas FDA

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

Gyrus Ent LLC — Predicate Candidate Screening

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

57 daysmedian FDA review time
129 days90th percentile
28clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K040996RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIGyrus Ent LLC2004-08-201260
K034004DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLEGyrus Ent LLC2004-03-03700
K033089HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEMGyrus Ent LLC2004-02-051292
K033554SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESISGyrus Ent LLC2003-11-24120
K030343DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDEDGyrus Ent LLC2003-05-02880
K021595GYRUS ENT NERVE STIMULATORGyrus Ent LLC2002-10-241620
K021777GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLAGyrus Ent LLC2002-08-26880
K020778GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 24Gyrus Ent LLC2002-05-28780
K020067GYRUS ENT SOMNOPLASTY GENERATORGyrus Ent LLC2002-04-04850
K020594DIEGO POWERED DISSECTOR AND DRILL SYSTEMGyrus Ent LLC2002-03-08140
K003214SMITH & NEPHEW PISTONSGyrus Ent LLC2000-10-31180
K002702NEUROTOLOGY DRAPE, MODEL TBDGyrus Ent LLC2000-10-26570
K002737SMITH & NEPHEW PORPS & TORPSGyrus Ent LLC2000-10-12410
K002464SMITH & NEPHEW OFF-CENTERED PORPGyrus Ent LLC2000-08-29190
K002378MODULAR PORP AND TORP MODEL TBDGyrus Ent LLC2000-08-29250
K002021HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADEGyrus Ent LLC2000-08-24520
K001902BOJRAB UNIVERSAL LONG IMLANT, MODEL TBDGyrus Ent LLC2000-07-10180
K000801PC COATED FLUOROPLASTIC VENT TUBESGyrus Ent LLC2000-06-19980
K000858WEHRS INCUS-STAPESGyrus Ent LLC2000-04-03180
K000256CAP PORP, CAP TORPGyrus Ent LLC2000-02-11140
K992994TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; Gyrus Ent LLC1999-11-23770
K992222FLUOROPLASTIC VENTILATION TUBESGyrus Ent LLC1999-08-26560
K990601BOJRAB MICRO-TORP, MODEL 7014-5845Gyrus Ent LLC1999-03-31350
K990213HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAGyrus Ent LLC1999-02-02110
K974311VOCOM (VOCAL CORD MEDIALIZATION) IMPLANTGyrus Ent LLC1998-03-041070
K974232ESSENTIAL SHAVER SYSTEMGyrus Ent LLC1998-01-12610
K973286ENT IRRIGATING PUMP (70327700)Gyrus Ent LLC1997-09-29270
K962564RICHARDS TOTAL/PARTIAL PROSTHESISGyrus Ent LLC1997-01-222050

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