Product code GCB
- Device name
- Needle, Catheter
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4200
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150800 | Valved Safety Centesis Catheter | B.Braun Medical, Inc. | 2015-11-12 |
| K974146 | PARACENTESIS CATHETER DEVICE | Allegiance Healthcare Corp. | 1998-01-28 |
| K930568 | ADAIR/VERESS NEEDLE INTRODUCER SET | Medical Dynamics, Inc. | 1993-07-22 |
| K923028 | TURKEL PNEUMOTHORAX KIT | Symbiosis Corp. | 1992-08-04 |
| K900374 | ADAIR/VERESS NEEDLE INTRODUCER SET | Medical Dynamics, Inc. | 1990-04-20 |
| K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES | Concord Laboratories, Inc. | 1985-11-13 |
| K852428 | MANAN EPIDURAL NEEDLE | Manan Manufacturing Co., Inc. | 1985-06-27 |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | Jelco Laboratories | 1978-08-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810068811084 | MONARCH™ Kit Catheter & Accessories | Auris Health, Inc. | 2026-05-05 |
| 10810068811060 | MONARCH™Guided Percutaneous Access Kit | Auris Health, Inc. | 2026-05-04 |
| 10841156111830 | TELEFLEX | TELEFLEX INCORPORATED | 2025-09-24 |
| 10841156111847 | TELEFLEX | TELEFLEX INCORPORATED | 2025-09-24 |
| 10841156111854 | TELEFLEX | TELEFLEX INCORPORATED | 2025-09-24 |
| 10841156111861 | TELEFLEX | TELEFLEX INCORPORATED | 2025-09-24 |
| 10841156110949 | TELEFLEX | TELEFLEX INCORPORATED | 2024-04-08 |
| 10841156110956 | TELEFLEX | TELEFLEX INCORPORATED | 2024-04-08 |
| 10841156110963 | TELEFLEX | TELEFLEX INCORPORATED | 2024-04-08 |
| 10841156110970 | TELEFLEX | TELEFLEX INCORPORATED | 2024-04-08 |
| 15711055001905 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055000083 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055001912 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055001929 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055001967 | M-Drain Centesis Catheter | Mermaid Medical A/S | 2019-08-05 |
| 15711055001974 | M-Drain Centesis Catheter | Mermaid Medical A/S | 2019-08-05 |
| 15711055001981 | M-Drain Centesis Catheter | Mermaid Medical A/S | 2019-08-05 |
| 15711055001998 | M-Drain Centesis Catheter | Mermaid Medical A/S | 2019-08-05 |
| 15711055002001 | M-Drain Centesis Catheter | Mermaid Medical A/S | 2019-08-05 |
| 15711055000304 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055000298 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055000281 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055000274 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055000267 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055000069 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055000052 | Access Needle | Mermaid Medical A/S | 2019-08-05 |
| 15711055002018 | M-Drain Centesis Catheter | Mermaid Medical A/S | 2019-08-05 |
| M9796800803M0 | SIALOGRAPHY UNIT ENDPORT, 30GA | RANFAC CORP. | 2017-05-09 |
| 08714729735502 | AccuStick™ Needle | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729862932 | AccuStick™ Needle | BOSTON SCIENTIFIC CORPORATION | 2016-08-17 |