Medisiss Reprocessed Non-Electric Gi Biopsy Forceps
FDA 510(k) K042659 · Medisiss
510(k) numberK042659
Submission
- Device name
- Medisiss Reprocessed Non-Electric Gi Biopsy Forceps
- Applicant
- Medisiss
Redmond, OR, US - Received
- September 28, 2004
- Decision date
- February 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NON – Forceps, Biopsy, Non-Electric, Reprocessed
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code NON
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| K100543 | Medississ Reprocessedent Ablation Wands (Coblators), MODEL#EIC8872-01GEI · Traditional | 07/23/2010SE |
| K081559 | GenesisGEI · Traditional | 08/28/2008SE |
| K030598 | Medisiss Reprocessed Ultrasonic Surgical InstrumentsNLQ · Traditional | 01/23/2004SE |
| K030919 | Siss, Inc. (D.B.A.Medisiss) Reprocessd Electrosurgical Instruments and AccessoriesNLR · Traditional | 07/03/2003SE |
Questions and answers
When was Medisiss Reprocessed Non-Electric Gi Biopsy Forceps cleared by the FDA?
Medisiss Reprocessed Non-Electric Gi Biopsy Forceps (K042659) received a 510(k) decision of Substantially Equivalent on February 14, 2005, 139 days after the submission was received.
What is the product code of K042659?
The FDA product code is NON – Forceps, Biopsy, Non-Electric, Reprocessed, a Class I (low risk) device regulated under 21 CFR 876.1075.