Company ยท US
Spenco Medical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1998. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMP | Protector, Skin Pressure | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 |
| KCZ | Prosthesis, Breast, External, Used With Adhesive | 1 |
| KGX | Tape And Bandage, Adhesive | 1 |
| KMF | Bandage, Liquid | 1 |
| MDA | Elastomer, Silicone, For Scar Management | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 1998 | K981902 | SPENCO SILICONE GEL SHEET Spenco Medical Corp. | MDA |
| Dec 11, 1992 | K922228 | 2ND SKIN STERILE ADHESIVE STRIP Spenco Medical Corp. | KGX |
| Sep 6, 1991 | K911550 | 2ND SKIN MOIST BURN PADS WITH ALOE Spenco Medical Corp. | MGQ |
| Jun 3, 1991 | K910927 | SPENCIO SKIN GUARD KIT Spenco Medical Corp. | KMF |
| Dec 13, 1989 | K896533 | SPENCO BREAST FORMS Spenco Medical Corp. | KCZ |
| Aug 23, 1989 | K894898 | 2ND SKIN NON-STICK MOIST BURN PADS Spenco Medical Corp. | FRO |
| May 13, 1982 | K820906 | SPENCO CRYOPRESS Spenco Medical Corp. | IMD |
| May 20, 1981 | K811184 | SPENCO DERMAL PADS Spenco Medical Corp. | FMP |
| Nov 20, 1979 | K791726 | HYDROGEL-PREP Spenco Medical Corp. | NAB |
| Sep 4, 1979 | K791162 | GELSKIN Spenco Medical Corp. | ILO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||