FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
K Number: K170456
·
Decision Apr 5, 2017
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
26
Applicant Total
32
Review Days
49
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Basic Information
- Device Name
- Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K Number
- K170456
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Sustainability Solutions
- Date Received
- February 15, 2017
- Decision Date
- April 5, 2017
- Product Code
- NLQ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NLQ), ordered by most recent decision date.
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)
FDA 510(k)
FDA Unclassified
·Unknown
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
FDA 510(k)
FDA Unclassified
·Unknown
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
FDA 510(k)
FDA Unclassified
·Unknown
Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
FDA 510(k)
FDA Unclassified
·Unknown
Medline ReNewal Reprocessed Harmonic ACE+7 Shears
FDA 510(k)
FDA Unclassified
·Unknown
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Stryker Sustainability Solutions
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| 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) | Aug 14, 2025 | Substantially Equivalent |
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| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | Jul 3, 2024 | Substantially Equivalent |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | Feb 20, 2024 | Substantially Equivalent |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Jul 25, 2023 | Substantially Equivalent |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 | Mar 28, 2023 | Substantially Equivalent |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | Mar 28, 2023 | Substantially Equivalent |
| K222019 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | Dec 4, 2022 | Substantially Equivalent |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) | May 25, 2022 | Substantially Equivalent |