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

Gyrus Medical, Inc. · Predicate Candidate Screening

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

108 daysmedian FDA review time

251 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050550	GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR	Gyrus Medical, Inc.	2005-11-09	251	0
K050460	GYRUS PLASMACISION AND PLASMABLEND ELECTRODES	Gyrus Medical, Inc.	2005-10-25	244	0
K041999	GYRUS PLASMA SKIN RESURFACING SYSTEM	Gyrus Medical, Inc.	2005-03-02	219	0
K041633	GYRUS PLASMACISION LAPAROSCOPIC SPATULA	Gyrus Medical, Inc.	2004-10-22	128	0
K024286	GYRUS OPEN FORCEPS	Gyrus Medical, Inc.	2003-11-17	329	6
K031085	GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIE	Gyrus Medical, Inc.	2003-07-21	108	0
K031081	EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS	Gyrus Medical, Inc.	2003-05-21	47	1
K031079	EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELEC	Gyrus Medical, Inc.	2003-05-21	47	0
K031082	EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK	Gyrus Medical, Inc.	2003-05-21	47	0
K031078	EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR	Gyrus Medical, Inc.	2003-05-16	42	1
K031080	EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYO	Gyrus Medical, Inc.	2003-05-16	42	1
K023111	GYRUS PLASMA SKIN RESURFACING SYSTEM	Gyrus Medical, Inc.	2003-03-13	175	0
K023493	PK ZIP WING CUTTING DISSECTOR	Gyrus Medical, Inc.	2002-11-13	26	0
K023492	EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FO	Gyrus Medical, Inc.	2002-11-13	26	8
K020585	ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT	Gyrus Medical, Inc.	2002-07-13	141	1

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