510(k) Report

FDA applicant

Gyrus Acmi, Inc.

Southborough, MA46 decisions1993–202645 recalls

FDA records 46 decisions for Gyrus Acmi, Inc. (Southborough, MA) from 1993 to 2026: 44 510(k) clearances and 2 original PMA approvals. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 88 predicates, 19 of them its own earlier devices. 45 recalls are linked to its devices.

FDA’s records also spell it “Gyrus-Acmi L.P.”, “Gyrus Acmi”.

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 Gyrus Acmi, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 12008: 52009: 42010: 42011: 32012: 42013: 12014: 32015: 32016: 52017: 22018: 32021: 12022: 22023: 22024: 12026 (partial year): 1
2007high 5 (2008) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2026

2014: 32015: 22019: 102020: 12021: 32022: 12023: 132024: 102025: 12026 (partial year): 1
2007high 13 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gyrus Acmi, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories21decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories3decisions
  • ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece3decisions
  • FASElectrode, Electrosurgical, Active, Urological2decisions
  • GEXPowered Laser Surgical Instrument2decisions
  • HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)2decisions

Also: FGE (1), HIH (1), LJE (1), FGB (1), FGA (1), LYA (1).

How long do its 510(k) reviews take?

Since 2016, its 14 510(k)s took a median of 142 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 137 days; 9 of its 14 were faster than that.

Whose devices does it build on?

Its devices cite 88 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 35 times; 19 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092682Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysGyrus Acmi, Inc. · 20094cite it
  • K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 20093cite it
  • K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 20103cite it
  • K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 20113cite it
  • K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser…Gyrus Acmi, Inc. · 20212cite it
  • K152219PK AIMGyrus Acmi, Inc. · 20151cites it

What has FDA decided for it lately?

  • K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc. · 2026
  • K233275RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope…Gyrus Acmi, Inc. · 2024
  • K231327POWERSEAL Sealer and DividerGyrus Acmi, Inc. · 2023
  • K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and…Gyrus Acmi, Inc. · 20238 recalls
  • K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
  • K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc. · 2022
  • K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser…Gyrus Acmi, Inc. · 20211 recall
  • P180007Spiration® Valve SystemGyrus Acmi, Inc. · 20181 recall

All 44 as Gyrus Acmi, Inc. →The one decision as Gyrus-Acmi L.P. →The one decision as Gyrus Acmi →

What has been recalled?

45 recalls linked to its devices; the latest:

  • K100896Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting…Feb 25, 2026Class II
  • K132383Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name…Oct 17, 2025Class II
  • K180086EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years)…Sep 13, 2024Class II
  • K221306Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection…Aug 13, 2024Class II
  • K221306Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection…Aug 13, 2024Class II
  • K221306Soltive Pro SuperPulsed Laser System, Model TFL-SLSMay 31, 2024Class II

Other applicant names beginning “Gyrus”

FDA records each applicant name separately; these may or may not be the same firm.

Gyrus Ent LLC 28Gyrus Medical, Inc. 23