Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical Surgical Instruments and Accessories
FDA 510(k) K024011 · Surgical Instruments Service and Savings, Inc.
Submission
- Device name
- Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical Surgical Instruments and Accessories
- Applicant
- Surgical Instruments Service and Savings, Inc.
Sisters, OR, US - Received
- December 4, 2002
- Decision date
- December 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- NLU – Forceps, Biopsy, Electric, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be…
Other 510(k)s with product code NLU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050136 | Reprocessed Hot Biopsy ForcepsNLU · Traditional | Sterilmed, Inc. | 07/20/2005SE |
| K033593 | Reprocessed Single Use Devices Biopsy ForcepsNLU · Traditional | Clearmedical, Inc. | 11/20/2003SE |
| K011800 | Vanguard Reprocessed Electric Biopsy ForcepsNLU · Traditional | Vanguard Medical Concepts, Inc. | 09/27/2001SE |
More from Vanguard Medical Concepts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K124033 | Medisiss Reprocessed Ultrasonic InstrumentsNLQ · Traditional | 01/07/2014SE |
| K031869 | Siss Inc. (D.B.A. Medisiss) Reprocessed Electrosurgical Instruments and AccessoriesGEI · Traditional | 12/24/2003SE |
| K030179 | Medisiss Phacoemulsification Tips/NeedlesNKX · Abbreviated | 01/24/2003SE |
| K012644 | Reprocessed Trocars and CannulasNLM · Traditional | 07/29/2002SE |
| K012669 | Reprocessed Electrosurgical ElectrodesGEI · Traditional | 06/27/2002SE |
| K012667 | Reprocessed Arthroscopic ShapersHRX · Traditional | 06/03/2002SE |
| K012658 | Reprocessed Compression Limb SleevesJOW · Traditional | 05/14/2002SE |
Questions and answers
When was Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical Surgical Instruments and Accessories cleared by the FDA?
Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical Surgical Instruments and Accessories (K024011) received a 510(k) decision of Substantially Equivalent on December 19, 2002, 15 days after the submission was received.
What is the product code of K024011?
The FDA product code is NLU – Forceps, Biopsy, Electric, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 876.4300.