510(k) Report

FDA applicant

Circon Video

Santa Barbara, CA14 decisions1990–20027 recalls

FDA records 14 decisions for Circon Video (Santa Barbara, CA) from 1990 to 2002: 14 510(k) clearances. Most are in product codes FGB (Ureteroscope And Accessories, Flexible/Rigid) and HIH (Hysteroscope (And Accessories)). Its devices cite 4 predicates, 0 of them its own earlier devices. 7 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, gastroenterology and urology panel, where it files most

How often FDA has decided Circon Video’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Circon Video since 2007.

Recalls per year

3in 2026

2018: 12023: 12025: 22026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • FGBUreteroscope And Accessories, Flexible/Rigid4decisions
  • HIHHysteroscope (And Accessories)1decision
  • FENDevice, Cystometric, Hydraulic1decision
  • HIFInsufflator, Laparoscopic1decision
  • KOBCatheter, Suprapubic (And Accessories)1decision
  • FFKLithotriptor, Electro-Hydraulic1decision

Also: GCJ (1), GEI (1), FAJ (1), FCW (1), HIG (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 14 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.

  • K914883Circon Acmi Gen Surg Instru for Mini Invasive SurgCircon Video · 19933cite it
  • K890328Adult ResectoscopeCircon Video · 19902cite it
  • K011849Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series…Circon Video · 20012cite it
  • K012925Dur-8, Models Dur-8Circon Video · 20012cite it
  • K012951Apn-2 Usa Series Flexible CholedochoscopeCircon Video · 20012cite it
  • K011876Dolphin II Fluid Management System, Model Dol-2Circon Video · 20022cite it

What has FDA decided for it lately?

  • K012758Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models MR-9, MR-9L,Circon Video · 2002
  • K011876Dolphin II Fluid Management System, Model Dol-2Circon Video · 2002
  • K011849Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series…Circon Video · 2001
  • K012929Flexible Pediatric Cystoureteroscope, Model Aur- 735Circon Video · 2001
  • K012951Apn-2 Usa Series Flexible CholedochoscopeCircon Video · 2001
  • K012925Dur-8, Models Dur-8Circon Video · 2001
  • K012265Metal Halide Light Source, Models MV-9088-T, MV-9088Circon Video · 2001
  • K012153Lowsley Suprapubic TractorCircon Video · 2001

All 14 as Circon Video →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K890328Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.Aug 24, 2026Class II
  • K890328Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.Aug 24, 2026Class II
  • K890328Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model…May 5, 2026Class II
  • K890328Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable…Jun 18, 2025Class II
  • K890328Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number…Jun 18, 2025Class II
  • K890328ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and…Oct 2, 2023Class II

Other applicant names beginning “Circon”

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

Circon Acmi 10Circon Corp. 6