Isolation Bag 3M
FDA 510(k) K832318 · 3M Company
510(k) numberK832318
Submission
- Device name
- Isolation Bag 3M
- Applicant
- 3M Company
Monrovia, CA, US - Received
- July 15, 1983
- Decision date
- October 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K933085 | Goodman BandageKGY · Traditional | Megadyne Medical Products, Inc. | 12/23/1993SE |
| K913678 | Trocar CatheterKGY · Traditional | Medovations, Inc. | 12/16/1991SE |
| K910914 | Surgical Tissue PouchKGY · Traditional | Cook Urological, Inc. | 03/28/1991SE |
| 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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| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
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Questions and answers
When was Isolation Bag 3M cleared by the FDA?
Isolation Bag 3M (K832318) received a 510(k) decision of Substantially Equivalent on October 31, 1983, 108 days after the submission was received.
What is the product code of K832318?
The FDA product code is KGY – Bag, Intestine, a Class I (low risk) device regulated under 21 CFR 878.4100.