SMITH & NEPHEW DAYLIGHTER(TM)
FDA 510(k) clearance K873786 · decided 1987-10-23
Clearance details
- K-number
- K873786
- Device name
- SMITH & NEPHEW DAYLIGHTER(TM)
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-17
- Decision date
- 1987-10-23
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- FSY
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| ZF 720 (K132551) | Umbel Corporation | 2014-06-30 |
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| MACH LED 2SC (K140460) | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| MACH LED 2MC (K140461) | Dr. Mach GmbH & Co. KG | 2014-04-03 |
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| VIDA LED SURGICAL LIGHTING SYSTEM (K132307) | Convida Healthcare & Systems Corporation | 2013-11-05 |
| AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (K131893) | Ajw Technology Consultants, Inc. | 2013-10-30 |
| ORICARE L2700 (K122875) | Oricare, Inc. | 2012-12-18 |
| CHROMOPHARE F 628 AND F 528 (K120392) | Berchtold GmbH & Co. KG | 2012-02-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |