510(k) K100537
- Device
- REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
- Applicant
- ASCENT HEALTHCARE SOLUTIONS
- 510(k) number
- K100537
- Product code
- NLQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-12
- Date received
- 2010-02-25
- Regulation
- 510(k) Premarket Notification
- Classification name
- Scalpel, Ultrasonic, Reprocessed
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAMONA KULIK
- Address
- 10232 S. 51st St. Phoenix AZ US 85044 85044
FDA Registration Numbers#
- 3024021261
- 3030153385
- 1061124
- 3032391
- 1018470
- 1056128
- 1417592
- 1650907
- 3011024991
- 2183744
- 3009350690
- 2011171
Source Documents#
Other 510(k) Records For Product Code NLQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) | Stryker Sustainability Solutions | 2025-08-14 |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | Stryker Sustainability Solutions | 2024-07-03 |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | Stryker Sustainability Solutions | 2024-02-20 |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis | Stryker Sustainability Solutions | 2021-03-16 |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2020-08-19 |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Sterilmed, Inc. | 2019-08-15 |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | Sterilmed, Inc. | 2019-04-15 |
| K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Surgical Instrument Service and Savings, Inc. | 2018-07-12 |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2017-07-03 |
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Stryker Sustainability Solutions | 2017-04-05 |
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis | Stryker Sustainability Solutions | 2017-02-23 |
| K151405 | Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology | Surgical Instrument Services and Savings(Dba Medline Renewal | 2016-01-26 |
| K150524 | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology | Surgical Instrument Services and Savings, Inc. | 2015-12-16 |
| K143562 | Reprocessed Cordless Ultrasonic Dissection Device | Sterilmed, Inc. | 2015-05-20 |
| K132566 | REPROCESSED HARMONIC SHEAR | Sterilmed, Inc. | 2014-06-14 |
Legacy Summary#
summary
FDA Review#
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