510(k) K042648
K042648 is an FDA 510(k) premarket notification submitted by Sterilmed, Inc. for the device "REPROCESSED COLD BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on July 20, 2005. The device falls under product code NON (Forceps, Biopsy, Non-Electric, Reprocessed), a Class I device regulated under 21 CFR 876.1075. Sterilmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2005
- Date Received
- September 28, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Biopsy, Non-Electric, Reprocessed
- Device Class
- Class I
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type
same as procode FCL except this product is for the reprocessed device. 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).