LX EMBEDDING CENTER
FDA 510(k) clearance K853463 · decided 1985-08-28
Clearance details
- K-number
- K853463
- Device name
- LX EMBEDDING CENTER
- Applicant
- Innovative Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-19
- Decision date
- 1985-08-28
- Days to decision
- 9 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Ivyland, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Innovative Medical Systems
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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SHARPX NEEDLE DESTRUCTION UNIT (P980015/S005) | Innovative Medical Systems, Inc. | 2002-06-12 |
| SHARPX NEEDLE DESTRUCTION UNIT (P980015/S004) | Innovative Medical Systems, Inc. | 2001-08-15 |
| SHARP(X)TM NEEDLE DESTRUCTION UNIT (P980015/S003) | Innovative Medical Systems, Inc. | 1999-09-17 |
| SHARP NEEDLE DESTRUCTION UNIT (P980015/S002) | Innovative Medical Systems, Inc. | 1999-03-19 |
| SHARP NEEDLE DESTRUCTION UNIT (P980015/S001) | Innovative Medical Systems, Inc. | 1998-12-14 |
| SHARPX (P980015) | Innovative Medical Systems, Inc. | 1998-08-06 |