Hydrogel-Prep
FDA 510(k) K791726 · Spenco Medical Corp.
510(k) numberK791726
Submission
- Device name
- Hydrogel-Prep
- Applicant
- Spenco Medical Corp.
Mchenry, IL, US - Received
- September 4, 1979
- Decision date
- November 20, 1979
- 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 |
|---|---|---|
| K981902 | Spenco Silicone Gel SheetMDA · Traditional | 06/25/1998SE |
| K922228 | 2ND Skin Sterile Adhesive StripKGX · Traditional | 12/11/1992SESK |
| K911550 | 2ND Skin Moist Burn Pads with AloeMGQ · Traditional | 09/06/1991SE |
| K910927 | Spencio Skin Guard KitKMF · Traditional | 06/03/1991SE |
| K896533 | Spenco Breast FormsKCZ · Traditional | 12/13/1989SE |
| K894898 | 2ND Skin Non-Stick Moist Burn PadsFRO · Traditional | 08/23/1989SE |
| K820906 | Spenco CryopressIMD · Traditional | 05/13/1982SE |
| K811184 | Spenco Dermal PadsFMP · Traditional | 05/20/1981SE |
| K791162 | GelskinILO · Traditional | 09/04/1979SE |
Questions and answers
When was Hydrogel-Prep cleared by the FDA?
Hydrogel-Prep (K791726) received a 510(k) decision of Substantially Equivalent on November 20, 1979, 77 days after the submission was received.
What is the product code of K791726?
The FDA product code is NAB – Gauze / Sponge,Nonresorbable For External Use, a Class I (low risk) device regulated under 21 CFR 878.4014.