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

Synergetics, Inc. — Predicate Candidate Screening

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

168 daysmedian FDA review time

266 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K121426	AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCE	Synergetics, Inc.	2012-07-10	57	19
K121675	VERSAVIT	Synergetics, Inc.	2012-06-21	15	4
K113857	SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE	Synergetics, Inc.	2012-04-23	115	0
K110924	DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS	Synergetics, Inc.	2011-12-07	247	3
K091441	SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE	Synergetics, Inc.	2009-10-30	168	0
K071482	STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000	Synergetics, Inc.	2007-12-20	204	1
K063489	STRYKER INTRADISCAL RF GENERATOR	Synergetics, Inc.	2007-05-23	187	0
K032598	SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE	Synergetics, Inc.	2003-11-24	91	0
K020220	ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETT	Synergetics, Inc.	2002-08-23	213	1
K010637	SONOTOME ULTRASONIC ASPIRATOR TIPS	Synergetics, Inc.	2001-04-20	46	0
K990568	SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SC	Synergetics, Inc.	1999-05-14	80	0
K982212	VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITA	Synergetics, Inc.	1998-12-02	162	0
K964005	SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE	Synergetics, Inc.	1997-06-09	275	0
K932668	OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER	Synergetics, Inc.	1994-02-23	266	0
K923725	OPHTHALMIC PHARCO NEEDLE	Synergetics, Inc.	1993-03-18	234	0
K923326	OPHTHALMIC VISCOINJECTOR DRIVE	Synergetics, Inc.	1992-09-30	85	0

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