SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
FDA 510(k) clearance K854327 · decided 1985-11-13
Clearance details
- K-number
- K854327
- Device name
- SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
- Applicant
- Concord Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-28
- Decision date
- 1985-11-13
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- GCB
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Keene, NH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Valved Safety Centesis Catheter (K150800) | B.Braun Medical, Inc. | 2015-11-12 |
| PARACENTESIS CATHETER DEVICE (K974146) | Allegiance Healthcare Corp. | 1998-01-28 |
| ADAIR/VERESS NEEDLE INTRODUCER SET (K930568) | Medical Dynamics, Inc. | 1993-07-22 |
| TURKEL PNEUMOTHORAX KIT (K923028) | Symbiosis Corp. | 1992-08-04 |
| ADAIR/VERESS NEEDLE INTRODUCER SET (K900374) | Medical Dynamics, Inc. | 1990-04-20 |
| MANAN EPIDURAL NEEDLE (K852428) | Manan Manufacturing Co., Inc. | 1985-06-27 |
| NEEDLES, DESIGN CHANGE, IV CATHETERS (K780896) | Jelco Laboratories | 1978-08-23 |
Recalls involving this device
No recalls on record reference this clearance.