FLEXIFLO ENTERAL PUMP SET
FDA 510(k) clearance K791531 · decided 1979-09-12
Clearance details
- K-number
- K791531
- Device name
- FLEXIFLO ENTERAL PUMP SET
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1979-08-10
- Decision date
- 1979-09-12
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- BSS
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Abbott Park, 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 |
|---|---|---|
| TurboSEAL Nasogastric Aspiration Tube (K142483) | Turboseal, L.P. | 2014-12-19 |
| ENTERAL FEEDING TUBE (K051480) | Biosearch Medical Products, Inc. | 2005-10-12 |
| MOSS TUBES, INC. NASAL TUBE - MARK IV (K984629) | Moss Tubes, Inc. | 1999-03-02 |
| ASPISAFE GASTRIC TUBE (K961711) | B.Braun Medical, Inc. | 1997-06-11 |
| GASTRIC, CATHETER, IRRIGATION & ASPIRATION (K933596) | Polamedco, Inc. | 1995-02-13 |
| RADIUS ENTERAL FEEDING TUBE (K930510) | Radius Intl., Inc. | 1995-02-01 |
| AN-10S ANDERSEN TUBE WITH STYLET (K935688) | H.W. Andersen Products, Inc. | 1994-12-30 |
| TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (K934348) | Tri-Med Specialties, Inc. | 1994-12-23 |
| XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A (K905573) | Zeon Medical Corp. | 1991-06-19 |
| ARGYLE POLYURETHANE SALEM SUMP TUBE (K910479) | Sherwood Medical Co. | 1991-04-19 |
| WILTEK NASAL BILIARY DRAINAGE SET (K894870) | Wiltek Medical, Inc. | 1989-12-21 |
| TECNOL NASO-GASTRIC TUBE HOLDER (K891187) | Tecnol New Jersey Wound Care, Inc. | 1989-05-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |