Medline ReNewal Reprocessed Harmonic ACE+7 Shears— 510(k) K193563
Substantially EquivalentSurgical Instrument Service and Savings Inc.(Dba Medline Ren
FDA 510(k) clearance K193563 for Medline ReNewal Reprocessed Harmonic ACE+7 Shears, Substantially Equivalent on 2020-08-19. Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren. Device class: Unclassified.
Clearance details
- Applicant
- Surgical Instrument Service and Savings Inc.(Dba Medline Ren
- Product code
- Code NLQ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, 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
- K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
More clearances from Surgical Instrument Service and Savings Inc.(Dba Medline Ren
view all- K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)
- K182588 — Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
- K170955 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
- K153745 — Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
- K151617 — Livewire Electrophysiology Catheter
Recalls naming K193563
K-number listed on FDA's recall record- Z-3095-2024 — Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
- Z-0120-2024 — MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193563.
Data sourced from openFDA. This site is unofficial and independent of the FDA.