Grip-A-Boots
FDA 510(k) K955463 · Sil-Med Corp.
510(k) numberK955463
Submission
- Device name
- Grip-A-Boots
- Applicant
- Sil-Med Corp.
Taunton, MA, US - Received
- November 29, 1995
- Decision date
- January 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXZ – Guard, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LXZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K834127 | Instrument Tip Protection CoversLXZ · Traditional | Devon Industries, Inc. | 02/17/1984SE |
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| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | 03/11/1996SE |
| K942709 | Mediastinal Silicone DrainsGBW · Traditional | 01/04/1996SN |
| K926496 | Sil-Slip (Coated/Regular(Non-Coated)Thoracic DrainGBX · Traditional | 05/24/1995SE |
| K926495 | Sil-Slip Round Wound Drain (Coated)/Blue StripeGBX · Traditional | 02/02/1994SE |
| K926408 | Sil-Slip Flat Suction DrainGBX · Traditional | 02/02/1994SE |
| K921424 | Sil-Med Flat Suction DrainGBX · Traditional | 09/28/1992SE |
Questions and answers
When was Grip-A-Boots cleared by the FDA?
Grip-A-Boots (K955463) received a 510(k) decision of Substantially Equivalent on January 23, 1996, 55 days after the submission was received.
What is the product code of K955463?
The FDA product code is LXZ – Guard, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.