STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU
FDA 510(k) clearance K914694 · decided 1992-01-16
Clearance details
- K-number
- K914694
- Device name
- STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-18
- Decision date
- 1992-01-16
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Warsaw, IN, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ATTUNE Revision Knee System (P830055/S360) | Depuy, Inc. | 2026-08-05 |
| LCS® Total Knee System (P830055/S368) | Depuy, Inc. | 2026-07-15 |
| LCS® Total Knee System (P830055/S367) | Depuy, Inc. | 2026-06-29 |
| LCS® Total Knee System (P830055/S366) | Depuy, Inc. | 2026-06-03 |
| LCS® Total Knee System (P830055/S362) | Depuy, Inc. | 2026-04-10 |
| LCS® Total Knee System (P830055/S363) | Depuy, Inc. | 2026-03-27 |
| LCS® Total Knee System (P830055/S361) | Depuy, Inc. | 2026-02-13 |
| LCS® Total Knee System (P830055/S358) | Depuy, Inc. | 2026-02-13 |