Panels › Gastroenterology, Urology › Product code FCM · Class 2
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Regulation 876.5130
1510(k)s in 12 months (60 all time)
0recalls in 12 months (43 all time)
16recalls that name a 510(k)
Top companies in FCM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 2026 | K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit C.R. Bard, Inc. | FCM |
| Jun 6, 2025 | K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter I Convatec Limited, GB | FCM |
| Aug 2, 2023 | K223821 | Self-Cath Closed System Coloplast | FCM |
| Oct 23, 2008 | K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM Amsino International, Inc. | FCM |
| Jun 1, 2007 | K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM Coloplast Manufacturing Us, LLC | FCM |
| Mar 15, 2007 | K070048 | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT Marian Medical, Inc. | FCM |
| May 23, 2003 | K030712 | AMSURE URETHRAL CATHETERIZATION TRAY Amsino International, Inc. | FCM |
| May 23, 2003 | K030664 | AMSURE FOLEY INSERTION TRAY Amsino International, Inc. | FCM |
| Jun 6, 2001 | K011055 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS Go Medical Industries Pty. , Ltd., AU | FCM |
| May 9, 2001 | K010420 | RUSCH MMG/O'NEIL CATHETER Rusch, Inc. | FCM |
| Mar 29, 2001 | K003873 | MENTOR SELF-CATH CLOSED SYSTEM Mentor Corp. | FCM |
| Dec 27, 2000 | K002803 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT Go Medical Industries Pty. , Ltd., AU | FCM |
| Feb 12, 1999 | K983010 | SELF CATH SET/SAFETY CATH Rusch Intl. | FCM |
| Dec 17, 1996 | K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET Rusch, Inc. | FCM |
| Jul 29, 1996 | K962254 | NHMC URETHRAL CATHETERIZATION TRAY National Healthcare Mfg. Corp., CA | FCM |
| Jun 21, 1996 | K962073 | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY Continental Medical Laboratories, Inc. | FCM |
| May 9, 1996 | K961442 | UNIVERSAL DRAINAGE TRAY Customed, Inc. | FCM |
| Apr 1, 1996 | K960215 | CPR URETHRAL CATHETER TRAY Custom Pack Reliability | FCM |
| Apr 1, 1996 | K960214 | CPR FOLEY CAHTETER KIT Custom Pack Reliability | FCM |
| Feb 29, 1996 | K960566 | NHMC FOLEY CATHETERIZATION TRAY National Healthcare Mfg. Corp., CA | FCM |
| Jun 15, 1995 | K951479 | CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE Trinity Laboratories, Inc. | FCM |
| May 30, 1995 | K950390 | URETHRAL CATHETERIZATION TRAY Medcare Custom Packaging, Inc. | FCM |
| Apr 21, 1995 | K951178 | UROLOGICAL CATHETER & ACCESSORIES Deroyal Industries, Inc. | FCM |
| Mar 24, 1995 | K950344 | HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER Acacia Laboratories, Inc. | FCM |
| Feb 27, 1995 | K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER Cypress Medical Products, Ltd. | FCM |
| Feb 27, 1995 | K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY Cypress Medical Products, Ltd. | FCM |
| Sep 8, 1994 | K942177 | FOLEY CATHETERIZATION TRAY Customed, Inc. | FCM |
| May 27, 1993 | K923538 | MON-A-THERM FOLEY KIT Mallinckrodt Medical | FCM |
| May 6, 1991 | K910653 | TOUCHLESS II INTERMITTENT CATHETER C.R. Bard, Inc. | FCM |
| Apr 2, 1991 | K910022 | MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT Medical Marketing Group | FCM |
| Nov 29, 1990 | K904158 | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY Welcon, Inc. | FCM |
| Oct 4, 1990 | K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS Superior Healthcare Group, Inc. | FCM |
| Aug 23, 1990 | K902508 | LAKE MALE EXTERNAL CATHETERIZATION KIT Lake Medical Products, Inc. | FCM |
| Jul 20, 1990 | K901185 | FOLEY CATHETER INSERTION TRAY (10CC) Orion Life Systems, Inc. | FCM |
| Jul 20, 1990 | K901184 | URETHRAL CATHETER TRAY (LATEX) Orion Life Systems, Inc. | FCM |
| Jul 20, 1990 | K901183 | URETHRAL CATHETER TRAY (PVC) Orion Life Systems, Inc. | FCM |
| Jul 20, 1990 | K901181 | CATHETER CARE TRAY Orion Life Systems, Inc. | FCM |
| Jul 20, 1990 | K901180 | FOLEY CATHETER INSERTION TRAY (30CC) Orion Life Systems, Inc. | FCM |
| Jan 24, 1990 | K896212 | URETHRAL CATHETERIZATION TRAYS Westmark, Sterile Packing Systems, Inc. (Sps) | FCM |
| Apr 10, 1979 | K790254 | FOLEY CATHETERIZATION TRAY Snyder Laboratories, Inc. | FCM |
| Mar 6, 1979 | K790272 | TRAY, URETHRAL CATHETERIZATION Snyder Laboratories, Inc. | FCM |
| Mar 6, 1979 | K790271 | TRAY AND BAG, CATHETERIZATION Snyder Laboratories, Inc. | FCM |
| Jul 31, 1978 | K780879 | URETHRO CATHETERIZATION TRAY Abco Dealers, Inc. | FCM |
| Jun 13, 1978 | K780735 | URINARY CATHETER CARE SET Shield Laboratories, Inc. | FCM |
| Mar 2, 1978 | K772277 | BLADDER RETENTION-CATHETHERIZATIONTRAY Latex Ind., Inc. | FCM |
| Feb 24, 1978 | K780268 | BLADDER CATH KIT W/OUT CATHETER Latex Ind., Inc. | FCM |
| Feb 24, 1978 | K772342 | ROBINSON KIT - 750014 & 750016 Latex Ind., Inc. | FCM |
| Feb 24, 1978 | K772341 | BLADDER KIT - 734000 Latex Ind., Inc. | FCM |
| Feb 24, 1978 | K772340 | CATHETERIZATION KIT 732016-732018 Latex Ind., Inc. | FCM |
| Feb 21, 1978 | K780124 | CATHETERIZATION PROCED. TRAY, URETHRAL Walpak Co. | FCM |
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