Tender-Sorb Drain Sponges
FDA 510(k) K802225 · Kendall Research Center
510(k) numberK802225
Submission
- Device name
- Tender-Sorb Drain Sponges
- Applicant
- Kendall Research Center
Barrington, IL, US - Received
- September 12, 1980
- Decision date
- September 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAB – Gauze / Sponge,Nonresorbable For External Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4014
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946015 | Ivalon External SpongeNAB · Traditional | Ivalon | 02/27/1995SE |
| K940755 | Isolyer (4X4, 8PLY)NAB · Traditional | Isolyer Co. | 05/02/1994SE |
| K931610 | Omnisorb II, Nonwoven Sponge, Sterile and NonNAB · Traditional | Omni Mfg., Inc. | 06/24/1993SE |
| K925590 | Multi-Trauma DressingNAB · Traditional | Gam Industries, Inc. | 04/08/1993SE |
| K926072 | K-Band and K-CrepeNAB · Traditional | Parema , Ltd. | 03/19/1993SE |
| K915591 | Sterile Gauze PadsNAB · Traditional | Eagle Medical, Inc. | 01/27/1993SE |
| K924650 | Gauze SpongesNAB · Traditional | Dav-Mar Medical Products, Inc. | 01/11/1993SE |
| K923602 | Absorbent Pad -- ModificationNAB · Traditional | Winfield Laboratories, Inc. | 12/07/1992SE |
| K923115 | ClinisorbNAB · Traditional | Hermitage Hospital Products, Inc. | 11/23/1992SE |
| K923378 | Usp Type Vii Gauze SpongesNAB · Traditional | E.W.A., Ltd. | 10/06/1992SE |
More from E.W.A., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K781357 | T.E.D. Sequential Compression SleevesJOW · Traditional | 09/20/1978SE |
| K780408 | Micronet Light Dressing SpongeNAB · Traditional | 03/22/1978SE |
| K780062 | Catheter/Hemostatic/GeriatricEZL · Traditional | 02/14/1978SE |
| K780120 | Anesthesia Tray, CaudalCAZ · Traditional | 02/06/1978SE |
| K772134 | Syringe, Irrigation, Pre-FilledKOA · Traditional | 11/28/1977SE |
| K772133 | Urine Specimen Collecting DeviceFCN · Traditional | 11/28/1977SE |
| K771655 | Curity PeakometerFFG · Traditional | 10/14/1977SE |
| K771079 | Curity Irrigation TrayGBX · Traditional | 09/15/1977SE |
| K771563 | Conform Elastic NettingFQM · Traditional | 09/12/1977SE |
| K771452 | Conform Stretch Bandage (5SIZES)ITG · Traditional | 09/12/1977SE |
Questions and answers
When was Tender-Sorb Drain Sponges cleared by the FDA?
Tender-Sorb Drain Sponges (K802225) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 14 days after the submission was received.
What is the product code of K802225?
The FDA product code is NAB – Gauze / Sponge,Nonresorbable For External Use, a Class I (low risk) device regulated under 21 CFR 878.4014.