Medisiss Reprocessed Ultrasonic Instruments
FDA 510(k) K124033 · Surgical Instruments Service and Savings, Inc.
510(k) numberK124033
Submission
- Device name
- Medisiss Reprocessed Ultrasonic Instruments
- Applicant
- Surgical Instruments Service and Savings, Inc.
Redmond, OR, US - Received
- December 28, 2012
- Decision date
- January 7, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments
- Device class
- Unclassified
Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code LFL). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at…
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| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…NLQ · Traditional | Stryker Sustainability Solutions | 08/14/2025SE |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special | Stryker Sustainability Solutions | 07/03/2024SE |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional | Stryker Sustainability Solutions | 02/20/2024SE |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisNLQ · Traditional | Stryker Sustainability Solutions | 03/16/2021SE |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 ShearsNLQ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 08/19/2020SE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | Sterilmed, Inc. | 08/15/2019SE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional | Sterilmed, Inc. | 04/15/2019SE |
| K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional | Surgical Instrument Service and Savings, Inc. | 07/12/2018SE |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 07/03/2017SE |
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | Stryker Sustainability Solutions | 04/05/2017SE |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K024011 | Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical…NLU · Traditional | 12/19/2002SE |
| 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 Medisiss Reprocessed Ultrasonic Instruments cleared by the FDA?
Medisiss Reprocessed Ultrasonic Instruments (K124033) received a 510(k) decision of Substantially Equivalent on January 7, 2014, 375 days after the submission was received.
What is the product code of K124033?
The FDA product code is NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments, a Unclassified device.