HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)— 510(k) K000723

Clearance details

Applicant

Rochester Medical Corp.

Product code

Code KOD

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

2000-03-06

Decision date

2000-05-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stewartville, MN, US

• K251864 — Rubber Utility Catheter2026-02-23
• K220036 — Wellead Ureteral Catheter2022-12-16
• K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters2022-10-13
• K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr2021-11-19
• K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter2019-05-24

• K122785 — HYDROSIL; MAGIC; PERSONAL CATHETER2013-05-14
• K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT2004-06-10
• K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER2000-07-07
• K981612 — ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER1998-07-08
• K971627 — SILICONE ANTIBACTERIAL FOLEY CATHETER1998-01-13

Death

5

Injury

1,129

Malfunction

7,019

Total

8,153

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-3117-2026 — Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300¿ 10801741183307 00801741183218¿ 10801741183215 00801741183232 10801741183239 00801741183225¿ 10801741183222 00801741183249 10801741183246 00801741183263¿ 10801741183260 00801741183270¿ 10801741183277 00801741183287¿ 10801741183284 Preamendment REF: INTL14 INTL15 INTL16 INTP14 UDI code: 00801741183164¿ 10801741183161 00801741183171¿ 10801741183178 00801741183188 10801741183185 00801741183294 10801741183291 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.Class II·Ongoing·C.R. Bard Inc·20260625
• Z-0666-2022 — BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14CClass II·Ongoing·C.R. Bard Inc·20220127
• Z-0667-2022 — BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16CClass II·Ongoing·C.R. Bard Inc·20220127
• Z-1307-2018 — HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Class II·Terminated·C.R. Bard, Inc.·20170914
• Z-1308-2018 — Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.Class II·Terminated·C.R. Bard, Inc.·20170914
• Z-1309-2018 — Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612G, 53614G, 53616G, 53618G, 62308, 62310, 62606P, 602608, 62608P, 62610, 62610P, 63310, 63316, 63610, 63610M, 63612, 63612M, 63614, 63614M, 63616, 63616M, 63618, 71410, 72608, 72610, 73612, 73614, 73616 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Class II·Terminated·C.R. Bard, Inc.·20170914
• Z-2732-2015 — Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary CatheterClass II·Terminated·C.R. Bard, Inc.·20150824
• Z-2384-2015 — Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610. Intermittent catheter.Class II·Terminated·C.R. Bard, Inc.·20150707
• Z-2385-2015 — Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.Class II·Terminated·C.R. Bard, Inc.·20150707
• Z-2386-2015 — Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.Class II·Terminated·C.R. Bard, Inc.·20150707
• Z-2387-2015 — Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616. Intermittent catheter.Class II·Terminated·C.R. Bard, Inc.·20150707
• Z-2388-2015 — Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.Class II·Terminated·C.R. Bard, Inc.·20150707

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000723.