510(k) Report

FDA applicant

Cabot Medical Corp.

Langhorne, PA38 decisions1983–19964 recalls

FDA records 38 decisions for Cabot Medical Corp. (Langhorne, PA) from 1983 to 1996: 38 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HET (Laparoscope, Gynecologic (And Accessories)). Its devices cite 4 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Cabot Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cabot Medical Corp. since 2007.

Recalls per year

1in 2010

2007: 32010: 1
2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Cabot Medical Corp.’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?

  • GCJLaparoscope, General & Plastic Surgery7decisions
  • HETLaparoscope, Gynecologic (And Accessories)3decisions
  • HIGInsufflator, Hysteroscopic3decisions
  • HRXArthroscope3decisions
  • HIFInsufflator, Laparoscopic2decisions
  • HGIElectrocautery, Gynecologic (And Accessories)2decisions

Also: KNS (2), GEX (2), HIH (2), DWJ (1), HES (1), LHC (1).

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 11 times; 0 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.

  • K924530Cabot Medical Niagara (TM) 3.0 Liter High Flow IrriCabot Medical Corp. · 19933cite it
  • K932626Cabot Medical Surgiflex (R) Suction-Irrigation ProbCabot Medical Corp. · 19942cite it
  • K932293Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 19942cite it
  • K951972Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic SheathsCabot Medical Corp. · 19952cite it
  • K946109Cabot Medical Reusable Bipolar Cutting ForcepsCabot Medical Corp. · 19951cites it
  • K923945Pleatman Sac Specimen ContainerCabot Medical Corp. · 19931cites it

What has FDA decided for it lately?

  • K960148Circon-Surgitek Classic Double Pigtail Ureteral StentCabot Medical Corp. · 1996
  • K946109Cabot Medical Reusable Bipolar Cutting ForcepsCabot Medical Corp. · 1995
  • K951972Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic SheathsCabot Medical Corp. · 1995
  • K951714Cabot Medical-Surgitek Ultragold Plus Side-Firing Urologic Laser FiberCabot Medical Corp. · 1995
  • K941743Cabot Medical Niagara Fluid Management PumpCabot Medical Corp. · 1995
  • K9341153000 Electronic Insufflator ModificationCabot Medical Corp. · 1995
  • K932293Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 19943 recalls
  • K930954The Cabot Medical Insul-Sheth Vaginal Speculum CovCabot Medical Corp. · 1994

All 38 as Cabot Medical Corp. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K923945The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while…Aug 3, 2010
  • K932293Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number…Feb 19, 2007
  • K932293Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32Feb 19, 2007
  • K932293Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901Feb 19, 2007

Other applicant names beginning “Cabot”

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

Cabot Safety Corp. 3