Atlas FDA

REPROCESSED HARMONIC

FDA 510(k) clearance K012571 · decided 2001-11-07

Clearance details

K-number
K012571
Device name
REPROCESSED HARMONIC
Applicant
Sterilmed, Inc.
Decision
Substantially Equivalent
Date received
2001-08-09
Decision date
2001-11-07
Days to decision
90 days
Clearance type
Traditional
Product code
NLQ
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Sterilmed

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
Medline ReNewal Reprocessed Harmonic ACE+7 Shears (K193563)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2020-08-19
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

Recalls involving this device

RecordFirmDate
Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS recall (Z-0559-2009)Sterilmed Inc2009-01-13