510(k) K142483
- Device
- TurboSEAL Nasogastric Aspiration Tube
- Applicant
- TurboSEAL, L.P.
- 510(k) number
- K142483
- Product code
- BSS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-12-19
- Date received
- 2014-09-04
- Regulation
- 876.5980
- Classification name
- Tube, Nasogastric
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DORON BESSER
- Address
- 7 Haarad St. Tel Aviv IL 6971060 6971060
FDA Registration Numbers#
- 3011270181
- 2025851
- 9611590
- 3006795797
- 3006082230
- 1018233
- 1319639
- 3010280860
- 1320599
- 3012494290
Source Documents#
Other 510(k) Records For Product Code BSS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051480 | ENTERAL FEEDING TUBE | Biosearch Medical Products, Inc. | 2005-10-12 |
| K984629 | MOSS TUBES, INC. NASAL TUBE - MARK IV | Moss Tubes, Inc. | 1999-03-02 |
| K961711 | ASPISAFE GASTRIC TUBE | B.Braun Medical, Inc. | 1997-06-11 |
| K933596 | GASTRIC, CATHETER, IRRIGATION & ASPIRATION | Polamedco, Inc. | 1995-02-13 |
| K930510 | RADIUS ENTERAL FEEDING TUBE | Radius Intl., Inc. | 1995-02-01 |
| K935688 | AN-10S ANDERSEN TUBE WITH STYLET | H.W. Andersen Products, Inc. | 1994-12-30 |
| K934348 | TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR | Tri-Med Specialties, Inc. | 1994-12-23 |
| K905573 | XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A | Zeon Medical Corp. | 1991-06-19 |
| K910479 | ARGYLE POLYURETHANE SALEM SUMP TUBE | Sherwood Medical Co. | 1991-04-19 |
| K894870 | WILTEK NASAL BILIARY DRAINAGE SET | Wiltek Medical, Inc. | 1989-12-21 |
| K891187 | TECNOL NASO-GASTRIC TUBE HOLDER | Tecnol New Jersey Wound Care, Inc. | 1989-05-30 |
| K791531 | FLEXIFLO ENTERAL PUMP SET | Abbott Laboratories | 1979-09-12 |
Legacy Summary#
summary
FDA Review#
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