FDA Product Code
FDA Product Code KOD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5130
510(k) Clearances — 238 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K861699 | CATHETER VALVES KV 100 & KV 100EH | Max Staubli , Ltd. | 1986-11-19 | Traditional | PDF ↗ |
| K862098 | PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH | Hall/Mccollum Laboratories, Inc. | 1986-11-12 | Traditional | PDF ↗ |
| K863082 | COOK-VPI INTERMITTENT CATHETER | Cook Urological, Inc. | 1986-11-07 | Traditional | PDF ↗ |
| K863354 | BIO-GUARD AB COATED CATHETER | Cook Urological, Inc. | 1986-11-04 | Traditional | PDF ↗ |
| K863958 | TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY | Cathaid, Inc. | 1986-11-04 | Traditional | PDF ↗ |
| K863281 | CARE + PLUS IRREGATION TRAY | Welmed Systems, Inc. | 1986-10-31 | Traditional | PDF ↗ |
| K863282 | CARE + PLUS CATHETER CARE TRAY | Welmed Systems, Inc. | 1986-10-31 | Traditional | PDF ↗ |
| K863517 | FOLEY CATHETERS | Instrumentation Industries, Inc. | 1986-10-31 | Traditional | PDF ↗ |
| K863302 | MODIFIED FOLEY CATHETER | Sheridan Catheter Corp. | 1986-10-03 | Traditional | PDF ↗ |
| K862484 | HCI Y-CONNECTOR | Hospital Concepts, Inc. | 1986-09-09 | Traditional | PDF ↗ |
| K860325 | PRISTINE CULTURE CATHETER | Hall/Mccollum Laboratories, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862124 | POLYMED LABORATORIES ALL SILICONE FOLEY CATHETER | Polymed Laboratories | 1986-08-14 | Traditional | PDF ↗ |
| K861200 | UROTOPO CATHETER | Houston Biomedical, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K861181 | NORTA TEFLON COATED LATEX BALLOON CATHETERS | Beiersdorf, Inc. | 1986-04-08 | Traditional | PDF ↗ |
| K860265 | TELESCOPE PROTECTION TUBE | R. J. Ltd., Ind. | 1986-04-07 | Traditional | PDF ↗ |
| K860337 | VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH. | Van-Tec, Inc. | 1986-03-25 | Traditional | PDF ↗ |
| K855076 | ANGIOMED URETER DIATION SETS | Angiomed U.S., Inc. | 1986-03-11 | Traditional | PDF ↗ |
| K860484 | CURITY & KENGUARD SILICONE COATED FOLEY CATHETER | The Kendal Co. | 1986-03-11 | Traditional | PDF ↗ |
| K855143 | ANGIOMED EXCHANGE DRAINAGE CATHETER SETS | Angiomed U.S., Inc. | 1986-03-11 | Traditional | PDF ↗ |
| K854625 | UROTEC CLOSED IRRIGATIION SYRINGE | Urotec Systems Corp. | 1986-03-04 | Traditional | PDF ↗ |
| K855140 | ANGIOMED RENAL DILATION SET | Angiomed U.S., Inc. | 1986-02-24 | Traditional | PDF ↗ |
| K855077 | ANGIOMED HARZMANN DISCS | Angiomed U.S., Inc. | 1986-01-21 | Traditional | PDF ↗ |
| K854443 | O'NEIL URINARY CATHETER INTRODUCER | Pennine Medical , Ltd. | 1986-01-08 | Traditional | PDF ↗ |
| K852084 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP | The Kendal Co. | 1985-09-20 | Traditional | PDF ↗ |
| K853207 | PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE | American Pharmaseal Div. Ahsc | 1985-09-12 | Traditional | PDF ↗ |
| K853337 | TROCAR/CANNULA/SHEATH SET | American Edwards Laboratories | 1985-08-23 | Traditional | PDF ↗ |
| K851160 | VAN-TEC GUIDE WIRE W/HYDROMER COATING | Van-Tec, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K851857 | UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER | Sheridan Catheter Corp. | 1985-07-15 | Traditional | PDF ↗ |
| K851684 | UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER | Urotec Systems Corp. | 1985-07-02 | Traditional | PDF ↗ |
| K851180 | IRRIGATION TRAY | Pace Pharmaceutical Services, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K851179 | CATHETER CARE TRAY | Pace Pharmaceutical Services, Inc. | 1985-04-25 | Traditional | PDF ↗ |
| K850790 | DIAFLEX OCCLUSION BALLOON CATHETER | American Edwards Laboratories | 1985-03-25 | Traditional | PDF ↗ |
| K850335 | URETEROSCOPY CATHETER | Inmed Corp. | 1985-03-12 | Traditional | PDF ↗ |
| K850285 | GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY | Premium Plastics, Inc. | 1985-02-28 | Traditional | PDF ↗ |
| K842420 | NORTA SILICONIZED LATEX BALLOON CATH. | Beiersdorf, Inc. | 1984-11-21 | Traditional | PDF ↗ |
| K842866 | URETHRAL CATHETERIZATION TRAY | Inmed Corp. | 1984-09-10 | Traditional | PDF ↗ |
| K842228 | AIMED FOLEY CATHETER VARIOUS SIZES | Tech-Cons Ltd., Intl. | 1984-09-10 | Traditional | PDF ↗ |
| K842890 | PERCUFIX CATHETER CUFF | Medi-Tech, Inc. | 1984-09-04 | Traditional | PDF ↗ |
| K841769 | INTERMITTENT URETHRAL CATHETER TRAY | Seamless Hospital Products Co. | 1984-08-24 | Traditional | PDF ↗ |
| K841941 | VAN-TEC OCCLUSION BALLOON CATHETER | Van-Tec, Inc. | 1984-08-08 | Traditional | PDF ↗ |
| K841819 | CORPAK FOLEY CATH TRAY W/16FR. TEFLON | Corpak Co. | 1984-07-19 | Traditional | PDF ↗ |
| K841678 | STERILE, FOLEY CATHETERS W/PTFE COAT | Abco Dealers, Inc. | 1984-07-19 | Traditional | PDF ↗ |
| K841511 | HAEMATURIA CATHETERS | Warne Surgical Products, Ltd. | 1984-07-12 | Traditional | PDF ↗ |
| K841544 | AMER. PHARMASEAL SILICONIZED LATEX | American Pharmaseal Div. Ahsc | 1984-07-09 | Traditional | PDF ↗ |
| K841727 | UROLOGICAL CATHETER & ACCESSORIES | Research Medical, Inc. | 1984-06-07 | Traditional | PDF ↗ |
| K841485 | UROLOGICAL KIT W/STERILE, WATER-FILL | Medline Industries, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K840839 | MMG FOLEY CATHETER | Medical Technologies of Georgia | 1984-04-17 | Traditional | PDF ↗ |
| K832363 | FOLEY CATHETERIZATION TRAY-VARIOUS | Inmed Corp. | 1984-03-07 | Traditional | PDF ↗ |
| K834438 | TEMPERATURE SENSING FOLEY CATHETER | C.R. Bard, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833719 | PREPACELL THIN NEEDLE ASPIRATION TRAY | Applied Medical Devices, Inc. | 1984-01-25 | Traditional | PDF ↗ |
| K833432 | CATHETER INSERTION KIT | Clinipad Corp. | 1983-12-28 | Traditional | PDF ↗ |
| K833790 | CURITY 100% SILICONE COUDE' CATHETER | The Kendal Co. | 1983-12-27 | Traditional | PDF ↗ |
| K832389 | CATHETER CARE TRAY | Inmed Corp. | 1983-09-19 | Traditional | PDF ↗ |
| K831743 | STERILE FOLEY CATHETERS & UROLOGICAL | Electromedics, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K832692 | CURITY CATHETER STRAP | The Kendal Co. | 1983-09-12 | Traditional | PDF ↗ |
| K831567 | FOLEY-TEMP | Mallinckrodt Critical Care | 1983-08-10 | Traditional | PDF ↗ |
| K832165 | IMPROVED SILICATH SILICONE ELASTOMER | Travenol Laboratories, S.A. | 1983-08-08 | Traditional | PDF ↗ |
| K831244 | URETERAL STONE EXTRACTOR CATHETER | American Edwards Laboratories | 1983-06-17 | Traditional | PDF ↗ |
| K831369 | LATEX URINARY CATHETERS | Wayne Surgical Products | 1983-05-27 | Traditional | PDF ↗ |
| K830359 | STERILE CATHERIZATION PROCEDURE TRAYS | Welcon, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K830444 | STERILE, ALL PURPOSE URETHRAL CATHETER | Abco Dealers, Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K823818 | CATHETER HOLDER | Danek Medical, Inc. | 1983-01-09 | Traditional | PDF ↗ |
| K821818 | RETRIEVAL BALLOONS | American Endoscopy, Inc. | 1982-09-24 | Traditional | PDF ↗ |
| K821970 | DYNACOR URETHRAL CATHETER TRAY | Medline Industries, Inc. | 1982-07-21 | Traditional | PDF ↗ |
| K821745 | BARDEX ALL SILICONE PEDIATRIC CATHETER | C.R. Bard, Inc. | 1982-06-24 | Traditional | PDF ↗ |
| K821272 | BN-74 COATED BARDEX ALL SILICONE CATH | C.R. Bard, Inc. | 1982-06-22 | Traditional | PDF ↗ |
| K820987 | FOLEY INSERTION TRAYS W/OVERWRAY | Inmed Corp. | 1982-05-13 | Traditional | PDF ↗ |
| K820838 | CURITY ECONOMY I CYSTOSCOPY | The Kendal Co. | 1982-05-11 | Traditional | PDF ↗ |
| K820866 | URETERAL CATHETER CONNECTING TUBE | Van-Tec, Inc. | 1982-04-26 | Traditional | PDF ↗ |
| K820868 | URETERAL CATHETER CONNECTOR | Van-Tec, Inc. | 1982-04-26 | Traditional | PDF ↗ |
| K820239 | RETRIEVAL FORCEPS | American Endoscopy, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K820637 | CATH-HOLD | Womco Products | 1982-03-25 | Traditional | PDF ↗ |
| K820419 | AM. PH. STERILE SINGLE-USE URETHRAL CATH | American Pharmaseal Div. Ahsc | 1982-03-23 | Traditional | PDF ↗ |
| K820313 | VPI-FAIR URETHRAL STENT | Vance Products, Inc. | 1982-03-01 | Traditional | PDF ↗ |
| K812995 | VANCE-JACOBELLIS MICROHEMATURIA CATHETER | Vance Products, Inc. | 1982-03-01 | Traditional | PDF ↗ |
| K812887 | ROBINSON CATHETERS NON-STERILE | Abco Dealers, Inc. | 1981-11-17 | Traditional | PDF ↗ |
| K811924 | PRE-FILLED SYRINGE & CYSTOFLO URINARY BG | Travenol Laboratories, S.A. | 1981-11-10 | Traditional | PDF ↗ |
| K812281 | TOUCHLESS HOME-CATH | Diamed Division Ill. Tool Works, Inc. | 1981-10-13 | Traditional | PDF ↗ |
| K811277 | CATH-DAP | Northwest Alabama Urological Assoc. | 1981-07-20 | Traditional | PDF ↗ |
| K810690 | CURITY 100% SILICONE SAFETY INDICATOR | The Kendal Co. | 1981-04-23 | Traditional | PDF ↗ |
| K810249 | TRAY, CATHERIZATION, URETHRAL | Megaplast, Inc. | 1981-04-07 | Traditional | PDF ↗ |
| K810630 | SILICONE ELASTOMER COATED LATEX FOLEY | G.D. Searle and Co. | 1981-03-31 | Traditional | PDF ↗ |
| K810367 | KISH URETHRAL ILLUMINATED CATHETER SET | Vance Products, Inc. | 1981-03-20 | Traditional | PDF ↗ |
| K810372 | VANCE DEFLECTABLE BIOPSY BRUSH SET | Vance Products, Inc. | 1981-03-20 | Traditional | PDF ↗ |
| K810281 | UROLOGICAL CATHETERS | Latex Ind., Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810216 | ARGYLE ROB-NELS | Sherwood Medical Co. | 1981-02-09 | Traditional | PDF ↗ |
| K803259 | CLOSED SYSTEM URETHRAL CATHETERIZ. SET | Medical Devices, Inc. | 1981-01-09 | Traditional | PDF ↗ |
| K803062 | CATH-SECURE | Melissa C. Johnson | 1981-01-07 | Traditional | PDF ↗ |
| K802878 | K-KATH URETHRAL CATHETER INTRODUCER | B&K Medical | 1981-01-02 | Traditional | PDF ↗ |
| K803080 | ALL PUPOSE URETHRAL CATHETER | American Hospital Supply Corp. | 1980-12-22 | Traditional | PDF ↗ |
| K803079 | FOLEY CATHETER | American Hospital Supply Corp. | 1980-12-22 | Traditional | PDF ↗ |
| K802875 | ARGYLE HEMATURIA BALLOON CATHETER | Sherwood Medical Co. | 1980-12-16 | Traditional | PDF ↗ |
| K802665 | TOUCHLESS CLEAN-CATH | Diamed Division Ill. Tool Works, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802516 | FOLEY CATHETER | Abco Dealers, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801820 | FOLEY CATHETERIZATION TRAY | Abco Dealers, Inc. | 1980-10-21 | Traditional | PDF ↗ |
| K801787 | URINARY CATHETER CARE TRAYS #3700&3710 | The Healthcare Group Laboratories, Inc. | 1980-10-21 | Traditional | PDF ↗ |
| K801785 | URETHRAL CATHETERIZATION TRAYS | The Healthcare Group Laboratories, Inc. | 1980-10-21 | Traditional | PDF ↗ |
| K801786 | URINE COLLECTION CONTAINERS, #3600 &3610 | The Healthcare Group Laboratories, Inc. | 1980-09-30 | Traditional | PDF ↗ |
| K802083 | CATHETER INSERTION TRAY | Walpak Co. | 1980-09-16 | Traditional | PDF ↗ |
| K801415 | LATEX FOLEY CATHETER (HYDROMER COATED) | G.D. Searle and Co. | 1980-08-20 | Traditional | PDF ↗ |
Product code KOD · Class II · Gastroenterology, Urology. Data: openFDA.