510(k) · Cleared
ClearedMedisiss Reprocessed Ultrasonic Surgical Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisiss · NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Cleared on Jan 23, 2004 as substantially equivalent to K980099 (Ethicon Endo-Surgery, Inc., 1998) and 4 other predicates after a 332-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Jan 23, 2004
- Review
- 332 days
- Class
- Class U
- Product code
- NLQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K801623 (1980). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 2 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 1 generation backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- This deviceK030598 Medisiss Reprocessed Ultrasonic Surgical InstrumentsMedisiss · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −2 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −1 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| 0 (this device) | K030598 | Medisiss Reprocessed Ultrasonic Surgical Instruments | Medisiss | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NLQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NLQ device
- #1 K233471 Reprocessed HARMONIC 1100 Shears, 5mm…score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Summary page 5…to the devices as listed below: Company 510(k) # Ethicon Endo-Surgery (Ultracision) K980099, K993054, and K010898 U.S.Surgical K971861 Olympus Optical… | 1998 |
| * | K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231…Summary page 5…evices as listed below: Company 510(k) # Ethicon Endo-Surgery (Ultracision) K980099, K993054, and K010898 U.S.Surgical K971861 Olympus Optical… | 1999 |
| * | K010898 | Ultracision Harmonic Scalpel Blades, Model DH105,DH145,SH105, SH145,HC145Summary page 5…ted below: Company 510(k) # Ethicon Endo-Surgery (Ultracision) K980099, K993054, and K010898 U.S.Surgical K971861 Olympus Optical… | 2001 |
| * | K971861 | Ultrasonic Hand InstrumentsSummary page 5…510(k) # Ethicon Endo-Surgery (Ultracision) K980099, K993054, and K010898 U.S.Surgical K971861 Olympus Optical K972114 They are also similar to the Reprocessed Ult… | 1997 |
| * | K972114 | Olympus Sonosurg SystemSummary page 5…K980099, K993054, and K010898 U.S.Surgical K971861 Olympus Optical K972114 They are also similar to the Reprocessed Ultrasonic Surgical Instruments reprocessed by SterilMed Cor… | 1998 |
| † | K012571 | Reprocessed Harmonic | 2001 |
| † | K022780 | Vanguard Reprocessed UltrasonicScalpel |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 14 ancestors has a recall.
- 5 other devices also cite its predicate K980099.
How does its category compare?
All NLQ devicesNLQ Single-Use Reprocessed Ultrasonic Surgical Instruments: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NLQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NLQ
94in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLQ
44in 2025
MAUDE reports naming product code NLQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 17 |
| 2008 | 0 | — | 1 | 25 |
| 2009 | 1 | — | 0 | 12 |
| 2010 | 2 | — | 0 | 33 |
| 2011 | 0 | — | 0 | 58 |
| 2012 | 1 | — | 0 | 113 |
| 2013 | 0 | — | 0 | 111 |
| 2014 | 3 | 303 | 0 | 63 |
| 2015 | 2 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 72 |
| 2017 | 3 | 94 | 0 | 87 |
| 2018 | 1 | — | 0 | 56 |
| 2019 | 2 | — | 0 | 45 |
| 2020 | 1 | — | 0 | 28 |
| 2021 | 1 | — | 0 | 40 |
| 2022 | 0 | — | 0 | 31 |
| 2023 | 0 | — | 1 | 16 |
| 2024 | 2 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SISS d.b.a. MediSISSTM Reprocessed Ultrasonic Surgical Instruments are intended 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 instruments. The instruments are used in general, pediatric, thoracic, gynecologic, urologic, and other open and endoscopic surgeries for the transection, dissection, and coagulation of tissue(s).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K030598 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030598: Medisiss Reprocessed Ultrasonic Surgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030598
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026