Sharpsite AC Rigid Endsocope
FDA 510(k) clearance K173855 · decided 2018-04-20
Clearance details
- K-number
- K173855
- Device name
- Sharpsite AC Rigid Endsocope
- Applicant
- Medtronic Xomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-12-20
- Decision date
- 2018-04-20
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic Xomed
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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S009) | Medtronic Xomed, Inc. | 1999-07-16 |
| LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S008) | Medtronic Xomed, Inc. | 1999-07-09 |
| LAMICEL(R) OSMOSTIC CERVICAL DILATOR (P820075/S007) | Medtronic Xomed, Inc. | 1996-01-03 |
| LAMICEL(R) OSSMOTIC CERVICAL DILATOR (P820075/S006) | Medtronic Xomed, Inc. | 1995-10-10 |
| LAMICEL(R) OSSMOTIC CERVICAL DILATOR (P820075/S005) | Medtronic Xomed, Inc. | 1991-10-09 |
| LAMICEL(TM) (P820075/S004) | Medtronic Xomed, Inc. | 1988-05-24 |
| LAMICEL(TM) (P820075/S002) | Medtronic Xomed, Inc. | 1986-08-22 |
| LAMICEL(TM) (P820075/S001) | Medtronic Xomed, Inc. | 1985-02-12 |