Goodman Bandage
FDA 510(k) K933085 · Megadyne Medical Products, Inc.
510(k) numberK933085
Submission
- Device name
- Goodman Bandage
- Applicant
- Megadyne Medical Products, Inc.
Draper, UT, US - Received
- June 23, 1993
- Decision date
- December 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGY – Bag, Intestine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4100
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KGY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K913678 | Trocar CatheterKGY · Traditional | Medovations, Inc. | 12/16/1991SE |
| K910914 | Surgical Tissue PouchKGY · Traditional | Cook Urological, Inc. | 03/28/1991SE |
| K832318 | Isolation Bag 3MKGY · Traditional | 3M Company | 10/31/1983SE |
| K801824 | Band-Aid Brand Flexible Fabric BandageKGY · Traditional | Johnson & Johnson Professionals, Inc. | 08/20/1980SE |
| K801823 | Band-Aid Brand Tricot Mesh BandagesKGY · Traditional | Johnson & Johnson Professionals, Inc. | 08/20/1980SE |
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| K133726 | Mega Soft Universal Patient Return ElectrodeGEI · Special | 01/24/2014SE |
| K080741 | Mega Soft Reusable Patient Return ElectrodeGEI · Traditional | 12/16/2008SE |
| K081791 | E-Z Clean Electrosurgical ElectrodeGEI · Traditional | 10/21/2008SE |
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Questions and answers
When was Goodman Bandage cleared by the FDA?
Goodman Bandage (K933085) received a 510(k) decision of Substantially Equivalent on December 23, 1993, 183 days after the submission was received.
What is the product code of K933085?
The FDA product code is KGY – Bag, Intestine, a Class I (low risk) device regulated under 21 CFR 878.4100.