TURKEL PNEUMOTHORAX KIT
FDA 510(k) clearance K923028 · decided 1992-08-04
Clearance details
- K-number
- K923028
- Device name
- TURKEL PNEUMOTHORAX KIT
- Applicant
- Symbiosis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-23
- Decision date
- 1992-08-04
- Days to decision
- 42 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
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Symbiosis Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| ADAIR/VERESS NEEDLE INTRODUCER SET (K900374) | Medical Dynamics, Inc. | 1990-04-20 |
| SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (K854327) | Concord Laboratories, Inc. | 1985-11-13 |
| 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.