GASTRIC LAVAGE KIT
FDA 510(k) clearance K780471 · decided 1978-06-02
Clearance details
- K-number
- K780471
- Device name
- GASTRIC LAVAGE KIT
- Applicant
- Gaymar Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-24
- Decision date
- 1978-06-02
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- FAT
- Device class
- 2
- Regulation number
- 876.5365
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
| STRYKER INFRAVISION ESOPHAGEAL KIT (K983220) | Stryker Endoscopy | 1999-06-04 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.