510(k) Report

FDA applicant

Surgical Instrument Service and Savings Inc.(Dba Medline Ren

Redmond, OR6 decisions2016–202413 recalls

FDA records 6 decisions for Surgical Instrument Service and Savings Inc.(Dba Medline Ren (Redmond, OR) from 2016 to 2024: 6 510(k) clearances. Most are in product codes NUJ (Electrosurgical, Cutting & Coagulation…) and NLQ (Single-Use Reprocessed Ultrasonic Surgical…). Since 2016 its 510(k)s took a median of 125 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. 13 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Surgical Instrument Service and Savings Inc.(Dba Medline Ren’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2016: 22017: 12018: 12020: 12024: 1
2016high 2 (2016) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

7in 2025

2023: 32024: 32025: 7, 2 Class I
2016high 7 (2025) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Surgical Instrument Service and Savings Inc.(Dba Medline Ren by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgical Instrument Service and…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2decisions
  • NLQSingle-Use Reprocessed Ultrasonic Surgical Instruments2decisions
  • NLHCatheter, Recording, Electrode, Reprocessed2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 125 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 133 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 20242 Class I recalls
  • K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren · 20202 recalls
  • K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren · 20185 recalls
  • K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren · 2017
  • K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren · 20164 recalls
  • K151617Livewire Electrophysiology CatheterSurgical Instrument Service and Savings Inc.(Dba Medline Ren · 2016

All 6 as Surgical Instrument Service and Savings Inc.(Dba Medline Ren →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K241224Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes…Dec 22, 2025Class I
  • K153745Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10…Oct 1, 2025Class II
  • K182588Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible with FT10…Oct 1, 2025Class II
  • K182588Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm…Oct 1, 2025Class II
  • K153745Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10…Oct 1, 2025Class II
  • K182588Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with FT10…Oct 1, 2025Class II