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

Edward Weck, Inc. — Predicate Candidate Screening

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

21 daysmedian FDA review time

99 days90th percentile

140clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K915378	WECK TROCAR	Edward Weck, Inc.	1992-06-29	213	0
K914690	LM15(TM), CATALOG NUMBER - 523821	Edward Weck, Inc.	1992-03-23	157	0
K911915	HEMOCLIP II	Edward Weck, Inc.	1992-01-09	254	0
K914470	PNEUMO-SEAL(TM)	Edward Weck, Inc.	1991-11-29	53	0
K911272	ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705	Edward Weck, Inc.	1991-07-02	102	0
K902108	HEM-O-LOK(TM)	Edward Weck, Inc.	1990-08-06	90	0
K902232	WECK ELECTROSURGICAL GENERATOR #174200	Edward Weck, Inc.	1990-08-02	77	0
K897045	BOWIE-DICK TEST CARD CATALOG NUMBER 008018	Edward Weck, Inc.	1990-02-15	58	1
K871110	CORONARY ARTERY BYPASS GRAFT (CABG) MARKER	Edward Weck, Inc.	1987-08-27	161	0
K851251	AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200	Edward Weck, Inc.	1985-07-02	97	0
K851258	WECK LX TM SKIN STAPLER	Edward Weck, Inc.	1985-06-07	71	0
K844836	HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER	Edward Weck, Inc.	1985-01-23	42	0
K844838	SKIN STAT II SKIN STAPLING MEDICAL DEVICE	Edward Weck, Inc.	1985-01-23	42	0
K844837	VISISTAT SKIN STAPLING DEVICE	Edward Weck, Inc.	1985-01-23	42	0
K841547	HEMOCLIP LIGATING CLIPS MED/SML	Edward Weck, Inc.	1984-08-14	120	0
K841548	HEMOCLIP LIGATING CLIPS M/LARGE	Edward Weck, Inc.	1984-08-14	120	0
K841549	HEMOCLIP AUTOMATIC CLIPS MEDIUM	Edward Weck, Inc.	1984-08-14	120	0
K833646	PULSATRON NERVE LOCATOR/STIMULATOR	Edward Weck, Inc.	1984-02-10	116	0
K833648	OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S	Edward Weck, Inc.	1983-11-29	43	0
K832795	HEIFETZ INTRACRANIAL ANEURYSM CLIPS	Edward Weck, Inc.	1983-11-25	99	0
K823901	TREPHINE BLADES-VARIOUS MODELS	Edward Weck, Inc.	1983-01-17	18	0
K822405	CONDUCTIVE ADHESIVE DISPERSIVE ELECTRO	Edward Weck, Inc.	1982-09-21	42	0
K810324	AUTOMATIC HEMOCLIP APPLIER, 527700	Edward Weck, Inc.	1981-03-20	42	0
K810391	VOGLER HYSTERECTOMY FORCEPS (SMALL & LG)	Edward Weck, Inc.	1981-03-04	15	0
K801609	MADDOX LENS SPATULA CAT. #7245	Edward Weck, Inc.	1980-08-13	29	0
K801468	FRAZIER-FERGUSON SUCTION TUBES	Edward Weck, Inc.	1980-08-12	49	0
K801608	MCCULLEY CONTINUOUS SUTURE TIGHTNER	Edward Weck, Inc.	1980-08-12	28	0
K801610	CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR	Edward Weck, Inc.	1980-08-04	20	0
K801612	FRAZIER-FERGUSON SUCTION TUBES (DISP.)	Edward Weck, Inc.	1980-08-04	20	0
K801611	DEEP BALFOUR BLADE FOR WILKINSON RETRACT	Edward Weck, Inc.	1980-08-04	20	0
K801465	GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE	Edward Weck, Inc.	1980-07-28	34	0
K801467	DODICK LENS HOLDING FORCEPS	Edward Weck, Inc.	1980-07-28	34	0
K801469	BONN MICRO IRIS HOOK (NON-STERILE) #7613	Edward Weck, Inc.	1980-07-28	34	0
K801466	LEIGH MEASURING SCALE #7725	Edward Weck, Inc.	1980-07-28	34	0
K801470	MICRO CLIP STERILIZING CASE #65199	Edward Weck, Inc.	1980-07-14	20	0
K801444	SKIN STAPLE REMOVER #523770	Edward Weck, Inc.	1980-07-14	24	0
K801445	SKIN STAPLER HANDLE 523700/CARTRIDGES	Edward Weck, Inc.	1980-07-14	24	0
K800721	GENERAL UTILITY SURG. SCISSORS #460180-	Edward Weck, Inc.	1980-05-08	37	0
K800368	OPHTHALMIC FORCEPS	Edward Weck, Inc.	1980-03-12	21	0
K800318	DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI	Edward Weck, Inc.	1980-03-10	27	0
K800367	MICRESURGICAL TRAY, SM.,MED., & LG.	Edward Weck, Inc.	1980-03-10	19	0
K800175	NASOSTAT	Edward Weck, Inc.	1980-02-21	24	0
K800079	HEMOCLIP SURGICAL OCCLUDING CLIP	Edward Weck, Inc.	1980-01-28	14	1
K800080	STERILIZING CASE CAT. NO. 65199	Edward Weck, Inc.	1980-01-28	14	0
K792576	CASTROVIEJO VASCULAR SCISSORS	Edward Weck, Inc.	1979-12-19	6	0
K792378	HEMOSPENSER CARTRIDGE CAT. NO. 523500-	Edward Weck, Inc.	1979-12-06	10	0
K792309	CASTROVIEJO VASCULAR NEEDLEHOLDER 538425	Edward Weck, Inc.	1979-11-30	14	0
K791988	REPL. PISTON FOR TROUTMAN CORNEAL PUNCH	Edward Weck, Inc.	1979-10-30	35	0
K792088	AORTIC OCCLUDER #000390	Edward Weck, Inc.	1979-10-26	9	0
K791845	BAYONET HEIFETZ CLIP APPLIERS	Edward Weck, Inc.	1979-10-17	28	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