ENDOBEAM
FDA 510(k) clearance K963044 · decided 1996-09-20
Clearance details
- K-number
- K963044
- Device name
- ENDOBEAM
- Applicant
- Corin USA
- Decision
- Substantially Equivalent
- Date received
- 1996-08-05
- Decision date
- 1996-09-20
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- GCT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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| CONMED LINVATEC 300W XENON LIGHT SOURCE (K070376) | Conmed Linvatec | 2007-08-20 |
| VIADUCT MINISCOPE AND ACCESSORIES (K040949) | Acueity, Inc. | 2004-05-07 |
| KSEA MEDI PACK (K022490) | KARL STORZ Endoscopy-America, Inc. | 2003-09-29 |
| LINVATEC 300W XENON LIGHT SOURCE (K031994) | Linvatec Corp. | 2003-08-21 |
| ENDOSCOPIC LIGHT SOURCE XL180/L3 (K023468) | World of Medicine Lemke GmbH | 2003-01-14 |
| ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 (K021717) | World of Medicine Lemke GmbH | 2002-08-20 |
| ENDOSCOPIC LIGHT SOURCE XL202/L3 (K020889) | World of Medicine Lemke GmbH | 2002-06-05 |
| DAYLITE XENON LIGHT SOURCES (K013880) | Designs For Vision, Inc. | 2001-12-07 |
| LUMENON XENON LIGHT SOURCE (K992050) | Walter Lorenz Surgical, Inc. | 1999-09-14 |
| XENON LIGHT SOURCE PES 1 (K992540) | Laser Optik Systeme GmbH & Co. KG | 1999-09-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Cormet Hip Resurfacing System (P050016/S012) | Corin USA | 2020-07-17 |
| CORMET HIP RESURFACING SYSTEM (P050016/S011) | Corin USA | 2016-12-21 |
| CORMET HIP RESURFACING SYSTEM (P050016/S010) | Corin USA | 2014-04-03 |
| CORMET HIP RESURFACING SYSTEM (P050016/S009) | Corin USA | 2013-03-22 |
| CORMET HIP RESURFACING SYSTEM (P050016/S008) | Corin USA | 2011-11-10 |
| CORMET HIP RESURFACING SYSTEM (P050016/S007) | Corin USA | 2011-01-13 |
| CORMET HIP RESURFACING SYSTEM (P050016/S006) | Corin USA | 2009-12-31 |
| CORMET HIP RESURFACING SYSTEM (P050016/S005) | Corin USA | 2009-12-03 |