WELCON LIGHT HANDLE
FDA 510(k) clearance K894397 · decided 1989-08-10
Clearance details
- K-number
- K894397
- Device name
- WELCON LIGHT HANDLE
- Applicant
- Welcon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-20
- Decision date
- 1989-08-10
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- FTA
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Providence, RI, 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.
| Record | Firm | Date |
|---|---|---|
| Universal Light Handle Cover, Light Handle Cover (K150532) | Key Surgical, Inc. | 2015-09-22 |
| Operating Room Light Handle Adapter (K142386) | Litex Manufacturing, Inc. | 2014-09-29 |
| SURGICAL LIGHT HANDLE COVER (K133554) | Microtek Medical, Inc. an Ecolab Company | 2014-04-08 |
| IDSS SLC (K133413) | Black Diamond Video | 2014-01-07 |
| OASYS SURGICAL LIGHT CONTROLLER (K112133) | Oasys Healthcare | 2012-03-01 |
| EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (K102791) | Image Stream Medical, Inc. | 2010-11-23 |
| MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (K081698) | Image Stream Medical, Inc. | 2008-07-30 |
| LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (K053321) | Xodus Medical, Inc. | 2006-01-19 |
| SCB/STERIS OR-LIGHT INTERFACE BOX (K051505) | KARL STORZ Endoscopy-America, Inc. | 2005-08-11 |
| KSEA SCB ACC CONTROL (K023704) | KARL STORZ Endoscopy-America, Inc. | 2003-01-30 |
| KSEA SCB MEDIA CONTROL (K020640) | KARL STORZ Endoscopy-America, Inc. | 2002-05-28 |
| DISPOSABLE LIGHT HANDLE AND ADAPTOR (K020304) | Aspen Surgical Products, Inc. | 2002-02-14 |
Recalls involving this device
No recalls on record reference this clearance.