Product code ILC
- Device name
- Utensil, Eating
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5050
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K833177 | GLOSSECTOMY FEEDING SPOONS | Maddak, Inc. | 1983-10-31 |
| K830854 | COLLAPSABLE LAVATORY SEAT HEIGHTENER | Lic-Orthion | 1983-04-05 |
| K830851 | BATH TUB SEAT & BATH BOARD | Lic-Orthion | 1983-04-05 |
| K823594 | PLASTIC BUILT-UP HANDLE EATING UTENSILS | Fred Sammons, Inc. | 1982-12-22 |
| K821643 | EATING UTENSILS | Fred Sammons, Inc. | 1982-06-11 |
| K813630 | BK-1129 BOTTLE STRAW | Fred Sammons, Inc. | 1982-01-19 |
| K812346 | ALUMINUM SCOOP DISK | Fred Sammons, Inc. | 1981-09-11 |
| K811488 | FEEDING AID KIT | Fred Sammons, Inc. | 1981-06-12 |
| K810455 | EATING UTENSILS | Fred Sammons, Inc. | 1981-03-04 |
| K801706 | BK-1426-00-01 STONYBROOK/HI-WALL PLATE | Fred Sammons, Inc. | 1980-08-07 |
| K801705 | BK-1424 INNER LIP PLATE, CERAMIC | Fred Sammons, Inc. | 1980-08-07 |
| K800019 | BK-1544 BE OK SCOOP DISK | Fred Sammons, Inc. | 1980-01-21 |
| K790170 | BK-1472 SPATULA SPOON | Fred Sammons, Inc. | 1979-02-13 |
| K781192 | KNIFE, ROCKER, SLOTTED HANDLE | Fred Sammons, Inc. | 1978-07-31 |
| K781196 | UTENSILS, WEIGHTED | Fred Sammons, Inc. | 1978-07-31 |
| K781193 | KNIFE, LARGE HANDLE | Fred Sammons, Inc. | 1978-07-31 |
| K781191 | SPORKS, PLASTIC, DISP. | Fred Sammons, Inc. | 1978-07-31 |
| K771274 | QUADRIPLEGIC MEAT KNIFE | Fred Sammons, Inc. | 1977-07-21 |
| K770169 | BEESON AUTOMADDAK FEEDER | Techhnilab Instruments, Inc. | 1977-01-28 |
| K761113 | BUILT-UP HANDLE UTENSILS | Fred Sammons, Inc. | 1976-12-02 |
| K761112 | PLASTIC HAND CONE | Fred Sammons, Inc. | 1976-12-02 |
| K761111 | SQUARE FOOD GUARD | Fred Sammons, Inc. | 1976-12-02 |
| K761107 | FOOD GUARDS | Fred Sammons, Inc. | 1976-12-02 |
| K761106 | WEIGHTED FORK | Fred Sammons, Inc. | 1976-12-02 |
| K761105 | WEIGHTED SPORK | Fred Sammons, Inc. | 1976-12-02 |
| K761104 | ADULT SWIVEL FORK | Fred Sammons, Inc. | 1976-12-02 |
| K760281 | CUP HOLDER/CUP, WHEELCHAIR | Fred Sammons, Inc. | 1976-09-08 |
| K760286 | SPOON, SOFT FOOD FEEDER, BK-1473 | Fred Sammons, Inc. | 1976-09-08 |
| K760285 | CONE, HAND, BK-1501 | Fred Sammons, Inc. | 1976-09-08 |
| K760284 | GLASS, NOSEY CUTOUT, BK-1146 | Fred Sammons, Inc. | 1976-09-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810226440111 | Vive | VIVE HEALTH LLC | 2026-06-04 |
| 00810226440104 | Vive | VIVE HEALTH LLC | 2026-06-04 |
| 00661392008076 | LSL HEALTHCARE | LSL Industries, LLC | 2025-05-15 |
| 10661392008073 | LSL HEALTHCARE | LSL Industries, LLC | 2025-05-15 |
| 00057475541019 | BIOS Living | Thermor Ltd | 2024-03-21 |
| 10057475541016 | BIOS Living | Thermor Ltd | 2024-03-21 |
| 30023601035074 | Carex | COMPASS HEALTH BRANDS CORP. | 2023-12-07 |
| 00023601035073 | Carex | Drive Devilbiss Healthcare | 2023-12-07 |
| 00194346098057 | EQUATE | Drive Devilbiss Healthcare | 2023-08-04 |
| 00859911004832 | SafeStraw | Bionix, LLC | 2023-07-19 |
| 00859911004825 | SafeStraw | Bionix, LLC | 2023-07-19 |
| 10686864048777 | SOLON | AMD Medicom Inc | 2023-07-10 |
| 10686864048821 | AMD-RITMED SOLON | AMD Medicom Inc | 2023-07-10 |
| 20714646000860 | SafeStraw™ 2 Pack | Bionix, LLC | 2022-10-27 |
| 00714646000866 | SafeStraw™ 2 Pack | Bionix, LLC | 2022-10-27 |
| 05060590889008 | Enteral | GBUK ENTERAL LIMITED | 2022-10-19 |
| 00859911004849 | SafeStraw™ Variety Pack | Bionix, LLC | 2022-01-06 |
| 00350770001890 | Straw Large Bore | Avanos Medical, Inc. | 2021-04-23 |
| 00350770001883 | Straw Large Bore | Avanos Medical, Inc. | 2021-04-23 |
| 00350770000312 | Avanos | Avanos Medical, Inc. | 2021-04-23 |
| 00350770000206 | ENFit Large Bore Straw | Avanos Medical, Inc. | 2021-04-02 |
| 00350770000190 | ENFit Large Bore Straw | Avanos Medical, Inc. | 2021-04-02 |
| 00350770000183 | ENFit Large Bore Straw | Avanos Medical, Inc. | 2021-04-02 |
| 10817522012827 | Ameritus | KENTEC MEDICAL, INC. | 2019-09-13 |
| 10817522010601 | Ameritus | KENTEC MEDICAL, INC. | 2019-09-13 |
| 00818323021370 | Vive | VIVE HEALTH LLC | 2019-03-18 |
| 10818323021377 | Vive | VIVE HEALTH LLC | 2019-03-18 |
| 00817584012950 | NeoMed Straw | NEOMED, INC. | 2016-09-19 |
| 00817584012905 | NeoMed Straw | NEOMED, INC. | 2016-09-19 |
| 00817584010185 | NeoMed Straw | NEOMED, INC. | 2016-09-19 |