Namic Rcs Syringe
510(k) K140194
Namic Rcs Syringe is a medical device (FDA Class II; FDA product code FMF, Syringe, Piston) made by Navilyst Medical, Inc., cleared under FDA 510(k) K140194 on 14 Apr 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140194 | Date14 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K140194
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FMF
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K140194
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| NAMIC 70127401 | 70127401 | H965701274010 | — | On the market |
| NAMIC 70127402 | 70127402 | H965701274020 | — | On the market |
| NAMIC 70127403 | 70127403 | H965701274030 | — | On the market |
| NAMIC 70127404 | 70127404 | H965701274040 | — | On the market |
| NAMIC 70127405 | 70127405 | H965701274050 | — | On the market |
| NAMIC 70127406 | 70127406 | H965701274060 | — | On the market |
| NAMIC 70127407 | 70127407 | H965701274070 | — | On the market |
| NAMIC 70127411 | 70127411 | H965701274110 | — | On the market |
| NAMIC 70127412 | 70127412 | H965701274120 | — | On the market |
| NAMIC 70127413 | 70127413 | H965701274130 | — | On the market |
| NAMIC 70127414 | 70127414 | H965701274140 | — | On the market |
| NAMIC 70127415 | 70127415 | H965701274150 | — | On the market |
| NAMIC 70127416 | 70127416 | H965701274160 | — | On the market |
| NAMIC 70127417 | 70127417 | H965701274170 | — | On the market |
| NAMIC 70127421 | 70127421 | H965701274210 | — | On the market |
| NAMIC 70127422 | 70127422 | H965701274220 | — | On the market |
| NAMIC 70127423 | 70127423 | H965701274230 | — | On the market |
| NAMIC 70127424 | 70127424 | H965701274240 | — | On the market |
| NAMIC 70127425 | 70127425 | H965701274250 | — | On the market |
| NAMIC 70127426 | 70127426 | H965701274260 | — | On the market |
| NAMIC 70127427 | 70127427 | H965701274270 | — | On the market |
| NAMIC 70127431 | 70127431 | H965701274310 | — | On the market |
| NAMIC 70127432 | 70127432 | H965701274320 | — | On the market |
| NAMIC 70127433 | 70127433 | H965701274330 | — | On the market |
| NAMIC 70127434 | 70127434 | H965701274340 | — | On the market |
| NAMIC 70127435 | 70127435 | H965701274350 | — | On the market |
| NAMIC 70127436 | 70127436 | H965701274360 | — | On the market |
| NAMIC 70127437 | 70127437 | H965701274370 | — | On the market |
| NAMIC 70127461 | 70127461 | H965701274610 | — | On the market |
| NAMIC 70127462 | 70127462 | H965701274620 | — | On the market |
| NAMIC 70127463 | 70127463 | H965701274630 | — | On the market |
| NAMIC 70127464 | 70127464 | H965701274640 | — | On the market |
| NAMIC 70127465 | 70127465 | H965701274650 | — | On the market |
| NAMIC 70127466 | 70127466 | H965701274660 | — | On the market |
| NAMIC 70127467 | 70127467 | H965701274670 | — | On the market |
Similar devices
Other devices filed under FDA product code FMF (Syringe, Piston).
- JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK) by Jiangsu Shenli Medical Production Factory
- CAPTION APPLICATOR by Smith & Nephew, Inc.
- INNOVO by Novo Nordisk A/S
- CONTROL SYRINGE by Professional Medical Services
- BD Plastipak Syringe by Becton, Dickinson and Company
- ULTICARE DISPOSABLE SYRINGES AND NEEDLES by ULTI MED, INC.
- DISPOSABLE DISC FILTER by The Medi-Dose Group
- COLORLESS DISPOSIBLE PLASTIC SYRINGES by Sam Joo Industrial Co., Ltd.
- MONOJECT STERILE M503 3CC SYRINGES by Sherwood Medical Co.
- MONJECT STERILE 20CC SYRINGES by Sherwood Medical Co.