STRYKER INFRAVISION ESOPHAGEAL KIT
FDA 510(k) clearance K983220 · decided 1999-06-04
Clearance details
- K-number
- K983220
- Device name
- STRYKER INFRAVISION ESOPHAGEAL KIT
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1998-09-14
- Decision date
- 1999-06-04
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- FAT
- Device class
- 2
- Regulation number
- 876.5365
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Clara, CA, 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 |
|---|---|---|
| PILLING ESOPHAGEAL BOUGIES (K133439) | Teleflexmedical, Inc. | 2014-06-16 |
| MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (K972119) | Medovations, Inc. | 1998-02-02 |
| INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (K960173) | Gabriel Medical, Inc. | 1996-06-27 |
| PYLORIC BALLOON DILATOR (K901425) | Telemed Systems, Inc. | 1990-06-21 |
| ESKA MULTISTAGE ESOPHAGEAL BOUGIE (K843186) | Dacomed Corp. | 1985-01-18 |
| ESOPHAGEAL DILATOR SET (K842679) | Mill-Rose Laboratory | 1984-10-02 |
| GASTRIC LAVAGE KIT (K780471) | Gaymar Industries, Inc. | 1978-06-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180 recall (Z-1002-2011) | Stryker Endoscopy | 2011-02-01 |
| Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufac recall (Z-0830-2011) | Stryker Endoscopy | 2010-12-28 |