REGANES SPINAL NEEDLE (VARIOUS)
FDA 510(k) clearance K971645 · decided 1997-08-01
Clearance details
- K-number
- K971645
- Device name
- REGANES SPINAL NEEDLE (VARIOUS)
- Applicant
- Avid N.I.T., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-05
- Decision date
- 1997-08-01
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MIA
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tarpon Springs, FL, 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 |
|---|---|---|
| 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 |
| 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 |
| SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM (K904380) | Custom Medical Concepts, Inc. | 1993-04-08 |
Recalls involving this device
No recalls on record reference this clearance.