Siss, Inc. (D.B.A.Medisiss) Reprocessd Electrosurgical Instruments and Accessories
FDA 510(k) K030919 · Medisiss
Submission
- Device name
- Siss, Inc. (D.B.A.Medisiss) Reprocessd Electrosurgical Instruments and Accessories
- Applicant
- Medisiss
Sisters, OR, US - Received
- March 24, 2003
- Decision date
- July 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- NLR – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current. This device is indicated for reuse/reprocessing. 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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| K081559 | GenesisGEI · Traditional | 08/28/2008SE |
| K042659 | Medisiss Reprocessed Non-Electric Gi Biopsy ForcepsNON · Traditional | 02/14/2005SE |
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Questions and answers
When was Siss, Inc. (D.B.A.Medisiss) Reprocessd Electrosurgical Instruments and Accessories cleared by the FDA?
Siss, Inc. (D.B.A.Medisiss) Reprocessd Electrosurgical Instruments and Accessories (K030919) received a 510(k) decision of Substantially Equivalent on July 3, 2003, 101 days after the submission was received.
What is the product code of K030919?
The FDA product code is NLR – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 876.4300.