SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM
FDA 510(k) clearance K904380 · decided 1993-04-08
Clearance details
- K-number
- K904380
- Device name
- SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM
- Applicant
- Custom Medical Concepts, Inc.
- Decision
- Unknown
- Date received
- 1990-09-26
- Decision date
- 1993-04-08
- Days to decision
- 925 days
- Clearance type
- Traditional
- Product code
- MIA
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Chelmsford, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Custom Medical Concepts
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 |
|---|---|---|
| Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors (K172800) | Smiths Medical Asd, Inc. | 2018-06-14 |
| FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 (K051860) | Epimed International, Inc. | 2005-08-22 |
| SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES (K983858) | Sims Portex, Inc. | 1999-01-29 |
| CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA (K982269) | Allegiance Healthcare Corp. | 1998-07-23 |
| REGANES SPINAL NEEDLE (VARIOUS) (K971645) | Avid N.I.T., Inc. | 1997-08-01 |
| NEO-CARE LUMBER PUNCTURE KIT (K970997) | Klein-Baker Medical, Inc. | 1997-05-22 |
| GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES (K961324) | Global Medical Prods, Inc. | 1996-07-02 |
| SPINAL NEEDLE (K960405) | Promex, Inc. | 1996-02-28 |
| ACUFEX T-FIX DELIVERY SYSTEM (K942442) | Acufex Microsurgical, Inc. | 1994-12-05 |
Recalls involving this device
No recalls on record reference this clearance.