FDA Product Code
FDA Product Code KNX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5250
510(k) Clearances — 206 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K110518 | IBAG | Future Path Medical, LLC | 2011-06-24 | Traditional | PDF ↗ |
| K973364 | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG | Maersk Medical A/S | 1998-03-17 | Traditional | PDF ↗ |
| K972887 | MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG | Medline Industries, Inc. | 1997-12-11 | Traditional | PDF ↗ |
| K971271 | BESECURE EXTERNAL URINARY COLLECTION SYSTEM | Urology Research Intl., Inc. | 1997-08-18 | Traditional | PDF ↗ |
| K971929 | AMSINO URINARY LEG BAG | Amsino Intl., Inc. | 1997-08-06 | Traditional | PDF ↗ |
| K971764 | WELCON HUE-VU URINARY DRAINAGE BAG | Welcon, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K964690 | LIBERTY VALVE | Cleveland Medical Devices, Inc. | 1997-03-21 | Traditional | PDF ↗ |
| K964745 | AMSINO URINARY DRAINAGE BAG | Amsino Intl., Inc. | 1997-03-18 | Traditional | PDF ↗ |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | Customed, Inc. | 1996-10-04 | Traditional | PDF ↗ |
| K960949 | PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 | Bristol-Myers Squibb | 1996-04-19 | Traditional | PDF ↗ |
| K952208 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-08-15 | Traditional | PDF ↗ |
| K944377 | ORION'S URINARY DRAINAGE SET | Regulatory & Marketing Services, Inc. | 1994-12-06 | Traditional | PDF ↗ |
| K944236 | NEEDLELESS URINE SAMPLING PORT | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-11-16 | Traditional | PDF ↗ |
| K940206 | BARD URINE COLLECTION PRODUCTS MODIFICATION | C.R. Bard, Inc. | 1994-09-16 | Traditional | PDF ↗ |
| K941447 | SIMPLA S4, S5, S7 | Simpla Plastics , Ltd. | 1994-07-18 | Traditional | PDF ↗ |
| K935557 | URINARY DRAINAGE BAG | Puritas Health Care, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K931459 | KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-06-14 | Traditional | PDF ↗ |
| K925067 | SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG | Simport Plastics, Ltd. | 1993-06-10 | Traditional | PDF ↗ |
| K926570 | HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878 | Hollister, Inc. | 1993-05-21 | Traditional | PDF ↗ |
| K921024 | URO-TOTE LEG BAG | Neotech Products, Inc. | 1992-09-02 | Traditional | PDF ↗ |
| K913142 | BODEN WHEELCHAIR DRAINAGE SYSTEM | Mno Medical Products | 1991-09-23 | Traditional | PDF ↗ |
| K913223 | STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES | Medical Device Inspection Co., Inc. | 1991-09-04 | Traditional | PDF ↗ |
| K901320 | ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG | Ep Medical, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K902417 | BAG, URINE | Gainor Medical Europe, Ltd. | 1990-07-16 | Traditional | PDF ↗ |
| K896688 | URINE COLLECTOR LEG BAG | Medline Industries, Inc. | 1990-05-02 | Traditional | PDF ↗ |
| K895168 | URO-BAGGIE | Cwt Workshop | 1990-03-22 | Traditional | PDF ↗ |
| K896727 | 4 SURE URINARY DRAIN BAG | The Boston & Pacific Co., Inc. | 1990-02-20 | Traditional | PDF ↗ |
| K896579 | GOOSEN URINARY DRAINAGE SYSTEM | Goosen Enterprises, Inc. | 1990-02-15 | Traditional | PDF ↗ |
| K895957 | L.T.C. 1000 URINARY DRAINAGE BAG | Intl. Medical Marketing, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K892437 | KENDALL KENGUARD URINARY LEG BAGS | The Kendal Co. | 1989-06-23 | Traditional | PDF ↗ |
| K892433 | KENDALL CURITY URINARY DRAINAGE BAGS | The Kendal Co. | 1989-05-05 | Traditional | PDF ↗ |
| K890551 | URINARY DRAINAGE UNIT | Consolidated Products & Services, Inc. | 1989-02-28 | Traditional | PDF ↗ |
| K890550 | CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE) | Consolidated Products & Services, Inc. | 1989-02-28 | Traditional | PDF ↗ |
| K881678 | SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP | Hollister, Inc. | 1988-08-11 | Traditional | PDF ↗ |
| K881217 | GENT-L-KARE STERILE URINARY LEG BAG | Geneva Laboratories, Inc. | 1988-07-29 | Traditional | PDF ↗ |
| K881213 | GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER | Geneva Laboratories, Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K880034 | CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT | Lin-Mark, Inc. | 1988-03-02 | Traditional | PDF ↗ |
| K874309 | URETHAL CATHETER | Medovations, Inc. | 1987-12-07 | Traditional | PDF ↗ |
| K872824 | P. URINE METER, 250CC | Ni-Med, Inc. | 1987-10-14 | Traditional | PDF ↗ |
| K873136 | MMG CATH-N-PLACE | Medical Technologies of Georgia | 1987-09-09 | Traditional | PDF ↗ |
| K871643 | CONVEEN(R) LEG-BAG (600 ML) | Coloplast A/S | 1987-06-10 | Traditional | PDF ↗ |
| K871610 | CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML) | Coloplast A/S | 1987-06-10 | Traditional | PDF ↗ |
| K871387 | SECOND NATURE(TM) | Advanced Clinical Products, Inc. | 1987-05-29 | Traditional | PDF ↗ |
| K870504 | NORTA (TM) UROBAG | Beiersdorf, Inc. | 1987-04-01 | Traditional | PDF ↗ |
| K871042 | URINE METER, 250CC | Salt Creek Medical Technologies | 1987-03-25 | Traditional | PDF ↗ |
| K864188 | E-Z HOLD WITH ADHESIVE BASE.-#4065 | John F. Greer Co., Inc. | 1986-12-04 | Traditional | PDF ↗ |
| K863739 | BESCURE | U-T, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K863671 | PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5 | Samco Industries, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K862581 | NEPHROSTOMY CONNECTING TUBE (A-50) | Advanced Clinical Products, Inc. | 1986-09-23 | Traditional | PDF ↗ |
| K862580 | NEPHROSTOMY DRAINAGE KIT (A-150) | Advanced Clinical Products, Inc. | 1986-09-23 | Traditional | PDF ↗ |
| K862251 | MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE | Bio-Flow, Inc. | 1986-09-04 | Traditional | PDF ↗ |
| K862934 | HOLLISTER FEMALE URINARY COLLECTION POUCH | Hollister, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K860362 | SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER | Travenol Laboratories, S.A. | 1986-04-29 | Traditional | PDF ↗ |
| K854821 | MMG EXTERNAL FEMALE CATHETERS | Medical Technologies of Georgia | 1986-04-24 | Traditional | PDF ↗ |
| K861192 | GENTLE BACK, PLASTIC URINARY DRAINAGE BAG | Advanced Clinical Products, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K861251 | AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N | American Medical Products, Inc. | 1986-04-17 | Traditional | PDF ↗ |
| K855209 | NIR LAT MALE EXTERNAL CATHETER | Mali, Inc. | 1986-01-10 | Traditional | PDF ↗ |
| K854580 | CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH | Coloplast A/S | 1985-12-13 | Traditional | PDF ↗ |
| K853892 | VISTA MED-URISTAT | Vista Med | 1985-12-02 | Traditional | PDF ↗ |
| K854480 | URINARY DRAINAGE BAG | The West Co., Inc. | 1985-11-19 | Traditional | PDF ↗ |
| K852490 | URI-CATH SYSTEM | Gesco Intl., Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K854173 | UCD URINE SPECIMEN COLLECTOR | Baker Instructions Corp. | 1985-11-04 | Traditional | PDF ↗ |
| K853458 | H-H SEXTON SCUP URINE MGMT. SYS | Holter-Hausner Intl. | 1985-08-27 | Traditional | PDF ↗ |
| K852619 | URI-SURE | Ashai Co. , Ltd. | 1985-08-27 | Traditional | PDF ↗ |
| K852051 | EXTERNAL MALE CATHETER | Buffalo Medical Specialties Mfg., Inc. | 1985-08-22 | Traditional | PDF ↗ |
| K852085 | KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG | The Kendal Co. | 1985-08-07 | Traditional | PDF ↗ |
| K844810 | NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG | C.R. Bard, Inc. | 1985-07-24 | Traditional | PDF ↗ |
| K851681 | SAFESTRETCH INCONTINENCE SYSTEM | Dbt Medical , Ltd. | 1985-06-28 | Traditional | PDF ↗ |
| K851266 | QRI-FLOW URINE FLOW MEASURING DEVICE | Bio-Flow, Inc. | 1985-06-27 | Traditional | PDF ↗ |
| K851471 | TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR | Lic-Orthion | 1985-06-12 | Traditional | PDF ↗ |
| K851470 | BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR | Lic-Orthion | 1985-06-12 | Traditional | PDF ↗ |
| K844155 | STANDARD URINARY DRAINAGE BAG & LEG BAG | Norris W. Whitlock | 1985-01-16 | Traditional | PDF ↗ |
| K844801 | ULTRA EXTERNAL CATHETER | Inmed Corp. | 1985-01-15 | Traditional | PDF ↗ |
| K844684 | COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM | Coloplast A/S | 1985-01-08 | Traditional | PDF ↗ |
| K843128 | FEMALE URINARY INCONTINENCE SYS | Chesebrough-Pond'S U.S.A. Co. | 1985-01-02 | Traditional | PDF ↗ |
| K843698 | CLOSED URINARY DRAINAGE UNIT | Pathfinder Intl. Corp. | 1984-12-17 | Traditional | PDF ↗ |
| K844280 | TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE | Travenol Laboratories, S.A. | 1984-12-17 | Traditional | PDF ↗ |
| K843478 | PHARMA-PLAST URIDROP-URIDOME | Zimmar Consulting , Ltd. | 1984-12-05 | Traditional | PDF ↗ |
| K843481 | PHARMA-PLAST CONNECTING TUBE TYPE URIN- | Zimmar Consulting , Ltd. | 1984-10-18 | Traditional | PDF ↗ |
| K843117 | GREEN CROSS URINARY DRAINAGE BAG | Tech-Cons Ltd., Intl. | 1984-10-11 | Traditional | PDF ↗ |
| K843480 | PHARMA-PLAST URINARY DRAINAGE BAG 2000 | Zimmar Consulting , Ltd. | 1984-10-11 | Traditional | PDF ↗ |
| K843479 | PHARMA-PLAST LEG BAG | Zimmar Consulting , Ltd. | 1984-10-11 | Traditional | PDF ↗ |
| K843126 | MEDIFLEX DRAINAGE BAG | Mediflex Intl. | 1984-10-04 | Traditional | PDF ↗ |
| K842397 | URIHESIVE SYS MALE EXTERNAL CATHETER | Convatec, A Division of E.R. Squibb & Sons | 1984-08-08 | Traditional | PDF ↗ |
| K842257 | CORPAK URINARY DRAINAGE BAG | Corpak Co. | 1984-08-08 | Traditional | PDF ↗ |
| K842396 | ACCUSEAL LEG BAGS & EXTENSION TUBES | Convatec, A Division of E.R. Squibb & Sons | 1984-08-08 | Traditional | PDF ↗ |
| K842395 | SUR-FIT NIGHT DRAINAGE CONTAINER SET | Convatec, A Division of E.R. Squibb & Sons | 1984-08-08 | Traditional | PDF ↗ |
| K832290 | CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE | Travenol Laboratories, S.A. | 1984-07-31 | Traditional | PDF ↗ |
| K842553 | CHESEBROUGH-POND'S REUSABLE URINARY LEG | Chesebrough-Pond'S U.S.A. Co. | 1984-07-20 | Traditional | PDF ↗ |
| K841197 | CYSTO-AID | E-Z-Em, Inc. | 1984-07-09 | Traditional | PDF ↗ |
| K841169 | CURITY RIG FOLEY CATH TRAY | The Kendal Co. | 1984-07-06 | Traditional | PDF ↗ |
| K841224 | URO-MALE INCONTINENCE CATHETER | Gil-Med Industries C/O Kegan & Kegan, Ltd. | 1984-05-02 | Traditional | PDF ↗ |
| K840917 | URINARY MONITORING SYS 240 | Vital Metrics, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840284 | MULTIPLE SYS-URINE DRAINAGE-CLOSED | Luth Corp. | 1984-04-13 | Traditional | PDF ↗ |
| K840283 | MULTIPLE BAG, LEG | Luth Corp. | 1984-04-13 | Traditional | PDF ↗ |
| K840703 | SECURE W/30MM DIAM, SHEATH & ADHESIVE | Warne Surgical Products, Ltd. | 1984-03-22 | Traditional | PDF ↗ |
| K840702 | SECURE W/25MM DIAM. SHEATH & ADHESIVE | Warne Surgical Products, Ltd. | 1984-03-22 | Traditional | PDF ↗ |
| K840704 | SECURE W/35MM DIAM, SHEATH/ADHESIVE | Warne Surgical Products, Ltd. | 1984-03-22 | Traditional | PDF ↗ |
| K840292 | URETHRAL CATH. TRAY W/BAG | Corpak Co. | 1984-03-16 | Traditional | PDF ↗ |
| K834337 | URIHESIVE SYSTEM - IMPROVED | Convatec, A Division of E.R. Squibb & Sons | 1984-02-10 | Traditional | PDF ↗ |
Product code KNX · Class II · Gastroenterology, Urology. Data: openFDA.