Atlas FDA

Medline ReNewal Reprocessed Harmonic ACE+7 Shears

FDA 510(k) clearance K193563 · decided 2020-08-19

Clearance details

K-number
K193563
Device name
Medline ReNewal Reprocessed Harmonic ACE+7 Shears
Applicant
Surgical Instrument Service and Savings Inc.(Dba Medline Ren
Decision
Substantially Equivalent
Date received
2019-12-23
Decision date
2020-08-19
Days to decision
240 days
Clearance type
Traditional
Product code
NLQ
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Redmond, OR, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Surgical Instrument Service and Savings Inc.(Dba Medline Ren

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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) (K250898)Stryker Sustainability Solutions2025-08-14
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) (K241606)Stryker Sustainability Solutions2024-07-03
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) (K233471)Stryker Sustainability Solutions2024-02-20
Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis (K202554)Stryker Sustainability Solutions2021-03-16
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (K190610)Sterilmed, Inc.2019-08-15
Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (K182272)Sterilmed, Inc.2019-04-15
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (K173627)Surgical Instrument Service and Savings, Inc.2018-07-12
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (K170955)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2017-07-03
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (K170456)Stryker Sustainability Solutions2017-04-05
Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis (K161693)Stryker Sustainability Solutions2017-02-23
Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology (K151405)Surgical Instrument Services and Savings(Dba Medline Renewal2016-01-26
Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology (K150524)Surgical Instrument Services and Savings, Inc.2015-12-16

Recalls involving this device

RecordFirmDate
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GE recall (Z-3095-2024)MEDLINE INDUSTRIES, LP - Northfield2024-09-10
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and recall (Z-0120-2024)MEDLINE INDUSTRIES, LP - Northfield2023-10-16