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

Surgitek — Predicate Candidate Screening

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

95 daysmedian FDA review time

189 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days
K946296	QUADRA-COIL URETERAL STENT	Surgitek	1995-03-06	69
K944391	OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM	Surgitek	1995-02-07	151
K943491	RIGHT ANGLE UROLOGIC LASER FIBER	Surgitek	1994-08-05	17
K941952	SURGITEK INFUSER	Surgitek	1994-05-24	32
K933260	HELICAL STONE/FLATWIRE STONE BASKETS	Surgitek	1994-01-11	189
K933261	GRASPING FORCEPS	Surgitek	1994-01-11	189
K930733	URETERAL STENT	Surgitek	1993-07-23	162
K930483	URETERAL CATHETER	Surgitek	1993-07-16	168
K926344	HYDROPHILIC COATED GUIDEWIRE	Surgitek	1993-03-05	78
K920451	ENDOTEK ULTRA SYSTEM	Surgitek	1992-09-17	226
K922542	GRASPING FORCEPS	Surgitek	1992-08-19	82
K904793	SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)	Surgitek	1991-03-05	133
K904797	SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)	Surgitek	1991-03-05	133
K905015	SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE	Surgitek	1990-12-28	51
K902349	SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER	Surgitek	1990-09-05	103
K894495	SURGITEK(R) EXTERNAL FILL PORT	Surgitek	1990-01-17	182
K891339	IRRI-FLO IRRIGATION DELIVERY SYSTEM	Surgitek	1989-06-02	84
K880660	SURGITEK SUPER DOUBLE J URETERAL STENT KIT	Surgitek	1988-04-14	57
K875333	SURGITEK NPT MONITOR	Surgitek	1988-04-13	105
K872353	SURGITEK INFUSION STENT SYSTEM*	Surgitek	1987-09-16	90
K870518	SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT	Surgitek	1987-04-29	83
K863492	METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.	Surgitek	1986-12-18	100
K833782	SURGITEK ALL SILICONE INFECTION DOUBJ	Surgitek	1984-04-02	157
K834347	FLEXI-FLATE PENILE IMPLANT	Surgitek	1984-04-02	111
K840464	TISSUE EXPANDER	Surgitek	1984-03-12	38
K840059	SILITEK URINARY DIVERSION STENT	Surgitek	1984-02-04	26
K833297	BRONCHOSCOPY TUBE W/ULTRA LOCUFF	Surgitek	1983-12-27	95
K833628	LUMEN-4 URODYNAMIC CATHETER	Surgitek	1983-11-28	45
K832915	URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN	Surgitek	1983-10-14	46

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