Bongort Special Odorproof Drain
FDA 510(k) K760735 · Howmedica Corp.
510(k) numberK760735
Submission
- Device name
- Bongort Special Odorproof Drain
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- September 28, 1976
- Decision date
- October 15, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EXB – Collector, Ostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Specialty
- Gastroenterology, Urology
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| K922730 | Lake Ostomy Care SetEXB · Traditional | Lake Medical Products, Inc. | 12/30/1993SESK |
| K882878 | Odor-End Emergency Clean Up PowderEXB · Traditional | Cdc Products Corp. | 12/08/1988SE |
| K881636 | Conseal Colostomy Continence System (One-Piece)EXB · Traditional | Coloplast A/S | 07/13/1988SE |
| K880306 | Emergency-Clean Up(Tm) EcpEXB · Traditional | Cdc Products Corp. | 05/20/1988SE |
| K872294 | Combination Nite Drainage UnitEXB · Traditional | Arnold Technologies | 12/29/1987SE |
| K873929 | 'Catch-It' or Fecal Containment DeviceEXB · Traditional | Midwest Medical Co. | 12/03/1987SE |
| K871526 | Odor-Safe(Tm)(Liquid) Odor-Safe(Tm) PowderEXB · Traditional | Cox Family Laboratories, Inc. | 10/13/1987SE |
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| K983885 | Burr Hole Covers, Craniomaxillofacial PlatesJEY · Traditional | 01/29/1999SE |
| K983528 | Micro Dynamic MeshJEY · Traditional | 12/23/1998SE |
| K983404 | Type 3 Femoral ComponentsLZO · Traditional | 12/22/1998SE |
| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Bongort Special Odorproof Drain cleared by the FDA?
Bongort Special Odorproof Drain (K760735) received a 510(k) decision of Substantially Equivalent on October 15, 1976, 17 days after the submission was received.
What is the product code of K760735?
The FDA product code is EXB – Collector, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.