510(k) Report

FDA applicant

Surgical Instrument Services and Savings, Inc.

Redmond, OR4 decisions2015–20233 recalls

FDA records 4 decisions for Surgical Instrument Services and Savings, Inc. (Redmond, OR) from 2015 to 2023: 4 510(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 151 days from receipt to decision, against 78 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. 3 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 Services and Savings, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12016: 12017: 12023: 1
2015high 1 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

3in 2025

2025: 3, 2 Class I
2015high 3 (2025) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Surgical Instrument Services and Savings, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2decisions
  • NLQSingle-Use Reprocessed Ultrasonic Surgical Instruments1decision
  • OWQReprocessed Intravascular Ultrasound Catheter1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 151 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 78 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, Inc. · 20232 Class I recalls
  • K162751Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/DividerSurgical Instrument Services and Savings, Inc. · 20171 recall
  • K152313Medline ReNewal Reprocessed Endopath Endoscopic InstrumentsSurgical Instrument Services and Savings, Inc. · 2016
  • K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc. · 2015

All 4 as Surgical Instrument Services and Savings, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x…Dec 22, 2025Class I
  • K162751Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT10…Oct 1, 2025Class II
  • K232130Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and…Jul 31, 2025Class I