510(k) · Cleared
ClearedSiss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisiss · NLR Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
Cleared on Jul 3, 2003 as substantially equivalent to K884306 (Circon Acmi, 1989) and 2 other predicates after a 101-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jul 3, 2003
- Review
- 101 days
- Class
- Class II
- Product code
- NLR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K952149 (1995). 4 ancestors in all, the oldest K884306 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backK952149 Karl Storz Take-Apart Rotating Grasping ForcepsKARL STORZ Endoscopy-America, Inc. · 1995
- 1 generation backK965176 Pilling Weck 2 Piece Take-Apart InstrumentsPilling Weck Group · 1997
- This deviceK030919 Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments…Medisiss · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952149 | Karl Storz Take-Apart Rotating Grasping Forceps | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| −1 | K965176 | Pilling Weck 2 Piece Take-Apart Instruments | Pilling Weck Group | 1997 | — |
| 0 (this device) | K030919 | Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments and… | Medisiss | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 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 NLR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K884306 | Bicap Ablating Forceps Baf-7Summary page 1…ents manufactured by: CircodACMI Weck (Pilling Surgical) These devices are legally marketed and distributed pursuant to 5 lO(k)’s K884306, K932293, and K965 176 and the counterpart devices from the original manufacturers. They are also simila… | 1989 |
| * | K932293 | Cabot Medical Bipolar Cutting ForcepsSummary page 1…CircodACMI Weck (Pilling Surgical) These devices are legally marketed and distributed pursuant to 5 lO(k)’s K884306, K932293, and K965 176 and the counterpart devices from the original manufacturers. They are also similar to the reprocessed… | 1994 |
| * | K965176 | Pilling Weck 2 Piece Take-Apart InstrumentsSummary page 1…CircodACMI Weck (Pilling Surgical) These devices are legally marketed and distributed pursuant to 5 lO(k)’s K884306, K932293, and K965 176 and the counterpart devices from the original manufacturers. They are also similar to the reprocessed electrosurgica… | 1997 |
| † | K012608 | Reprocessed electrosurgical instruments and accessories reprocessed by Alliance… | |
| † | K012638 | Reprocessed electrosurgical instruments and accessories reprocessed by Alliance… | |
| † | K012603 | Reprocessed Autosuture Unipolar Laparoscopic/Endoscopic Instruments | 2001 |
| † | K012696 | Adven Medical, Inc. Reprocessed Used Disposable Endoscopic Scissors and Graspers | |
| † | K012598 | Reprocessed Laparoscopic Electric Instuments | 2001 |
| † | K012700 | Vanguard Reprocessed Endoscopic Instruments | 2001 |
| † | K012669 | Reprocessed Electrosurgical Electrodes | 2002 |
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 8 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K884306.
How does its category compare?
All NLR devicesNLR Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NLR
FDA has decided no NLR device since 2007.
Median 510(k) review, days · NLR
Too few NLR 510(k)s in any year since 2007 to give a median.
Recalls per year · NLR
No recall names NLR since 2007.
Adverse event reports per year · NLR
1in 2025
MAUDE reports naming product code NLR, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation, transection, resection, mobilization, and dissections of tissue.
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/K030919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030919: Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030919
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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