Lake Ostomy Care Set
FDA 510(k) K922730 · Lake Medical Products, Inc.
510(k) numberK922730
Submission
- Device name
- Lake Ostomy Care Set
- Applicant
- Lake Medical Products, Inc.
St. Louis, MO, US - Received
- June 5, 1992
- Decision date
- December 30, 1993
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K181643 | SmartBag (SmartPouch)EXB · Traditional | 11 Health Technologies Limited | 11/16/2018SE |
| K140938 | Ostom-I AlertEXB · Traditional | 11 Health and Technologies, LLC | 10/10/2014SE |
| 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 |
| K871738 | Osto-PureEXB · Traditional | Clearchem Corp. | 08/12/1987SE |
More from Clearchem Corp.
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|---|---|---|
| K943162 | Lake Stagezero(Tm) Air Flotation BedFNM · Traditional | 02/27/1995SE |
| K905053 | Stage Zero Air Flotation BedIOQ · Traditional | 11/26/1990SE |
| K901835 | Lake N/G Feeding Tube (with Y Port Connector)KNT · Traditional | 09/05/1990SE |
| K902508 | Lake Male External Catheterization KitFCM · Traditional | 08/23/1990SESD |
| K902121 | Lake Gastrostomy TubeKGC · Traditional | 07/27/1990SE |
| K884127 | Lake N/G Feeding TubeKNT · Traditional | 02/08/1989SE |
| K884128 | Lake N/G Extension SetKNT · Traditional | 12/08/1988SE |
| K883610 | Lake Foley Catheterization TrayFCN · Traditional | 10/12/1988SE |
| K880578 | Lake Disposable Probe CoverFLL · Traditional | 03/31/1988SE |
| K875383 | Lake Catheter Care Kits (Modification)KOD · Traditional | 03/09/1988SESD |
Questions and answers
When was Lake Ostomy Care Set cleared by the FDA?
Lake Ostomy Care Set (K922730) received a 510(k) decision of Unknown on December 30, 1993, 573 days after the submission was received.
What is the product code of K922730?
The FDA product code is EXB – Collector, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.