Johnson & Johnson Ostomy Size Selector & Belt
FDA 510(k) K852297 · Johnson & Johnson Professionals, Inc.
510(k) numberK852297
Submission
- Device name
- Johnson & Johnson Ostomy Size Selector & Belt
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- May 29, 1985
- Decision date
- June 12, 1985
- 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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|---|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | Coloplast Corp. | 10/06/2025SE |
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| K140938 | Ostom-I AlertEXB · Traditional | 11 Health and Technologies, LLC | 10/10/2014SE |
| 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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| K983014 | Summit Acetabular SystemLPH · Traditional | 10/27/1998SE |
| K980778 | Hakim Micro Programmable Valve SystemJXG · Traditional | 07/17/1998SE |
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Questions and answers
When was Johnson & Johnson Ostomy Size Selector & Belt cleared by the FDA?
Johnson & Johnson Ostomy Size Selector & Belt (K852297) received a 510(k) decision of Substantially Equivalent on June 12, 1985, 14 days after the submission was received.
What is the product code of K852297?
The FDA product code is EXB – Collector, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.