FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
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)
K Number: K250898
·
Decision Aug 14, 2025
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
26
Applicant Total
32
Review Days
142
Basic Information
- Device Name
- 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)
- K Number
- K250898
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Sustainability Solutions
- Date Received
- March 25, 2025
- Decision Date
- August 14, 2025
- 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
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Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
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Other Clearances by Stryker Sustainability Solutions
| K Number | Device Name | ||
|---|---|---|---|
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Jun 18, 2026 | Substantially Equivalent |
| K241758 | 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) | Oct 22, 2024 | Substantially Equivalent |
| 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 |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | May 13, 2022 | Substantially Equivalent |