SHARPX
FDA premarket approval P980015 · decided 1998-08-06
Approval details
- PMA number
- P980015
- Trade name
- SHARPX
- Generic name
- Sharps needle destruction device
- Applicant
- Innovative Medical Systems, Inc.
- Date received
- 1998-05-08
- Decision date
- 1998-08-06
- Days to decision
- 90 days
- Decision code
- APRL
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Mountain Brook, AL
- Statement
- Approval for the Sharpx(TM) Needle Destruction Unit. The device is indicated for the destruction of 19 to 27 gauge hypodermic needles up to two inches in length. The unit is for use by healthcare professionals in out-patient and in-patient treatment settings and clinical laboratoreis.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VIOLA II DENTAL CAMERA SYSTEM (K973035) | Innovative Medical Systems, Inc. | 1997-09-24 |
| BAZOOKA SYSTEM (K951469) | Innovative Medical Systems, Inc. | 1995-06-28 |
| POSITIVE AIRWAY PRESSURE SYSTEM (K933184) | Innovative Medical Systems, Inc. | 1994-11-28 |
| MICROWAVE AUTOMATED TISSUE PROCESSOR (K924590) | Innovative Medical Systems, Inc. | 1992-12-29 |
| LABOTECH AUTOMATED MICROTITER ANALYZER (K922081) | Innovative Medical Systems, Inc. | 1992-09-02 |
| AUTOLOADER (K921005) | Innovative Medical Systems, Inc. | 1992-04-29 |
| PHACO 20/20 SYSTEM I (K915457) | Innovative Medical Systems, Inc. | 1992-02-24 |
| PHACO 3000 LINEAR (K915456) | Innovative Medical Systems, Inc. | 1992-02-12 |