Reprocessed Guidewires
FDA 510(k) K012556 · Sterilmed, Inc.
510(k) numberK012556
Submission
- Device name
- Reprocessed Guidewires
- Applicant
- Sterilmed, Inc.
Maple Grove, MN, US - Received
- August 8, 2001
- Decision date
- April 29, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NML – Catheter, Biliary, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
same as "FGE" except being reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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Questions and answers
When was Reprocessed Guidewires cleared by the FDA?
Reprocessed Guidewires (K012556) received a 510(k) decision of Substantially Equivalent on April 29, 2002, 264 days after the submission was received.
What is the product code of K012556?
The FDA product code is NML – Catheter, Biliary, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 876.5010.