Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis— 510(k) K161693
Substantially EquivalentStryker Sustainability Solutions
FDA 510(k) clearance K161693 for Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis, Substantially Equivalent on 2017-02-23. Applicant: Stryker Sustainability Solutions. Device class: Unclassified.
Clearance details
- Applicant
- Stryker Sustainability Solutions
- Product code
- Code NLQ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
Recent devices under product code NLQ
view all- K250898 — Reprocessed HARMONIC 700 Shears (3 models)
- K241606 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120) +1 more
- K233471 — Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120) +1 more
- K202554 — Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
- K193563 — Medline ReNewal Reprocessed Harmonic ACE+7 Shears
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view all- K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
- K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) +3 more
- K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031)
- K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- K230255 — Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019
Recalls naming K161693
K-number listed on FDA's recall record- Z-1327-2021 — Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.
- Z-2484-2018 — Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE¿+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand controls button.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161693.
Data sourced from openFDA. This site is unofficial and independent of the FDA.