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FDA 510(k)

DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2

K-Number: K011876 · 2002-01-08

ApplicantCircon Video
Decision Date2002-01-08
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 is the device name listed in this FDA 510(k) record. The listed applicant is Circon Video. It received FDA 510(k) clearance on 2002-01-08 under 510(k) number K011876. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2?

DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 is a medical device that received FDA 510(k) clearance on 2002-01-08. The listed applicant is Circon Video. The 510(k) number is K011876.

When did DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 receive FDA 510(k) clearance?

DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 received FDA 510(k) clearance on 2002-01-08, under 510(k) number K011876.

Who is the listed applicant for DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2?

The FDA 510(k) record lists Circon Video as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2?

The FDA product code for DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 is HIG.

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Other records listing Circon Video as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,K011849MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROSK012929FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735K012951APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPEK012925DUR-8, MODELS DUR-8K012265METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088

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Related Devices (Code: HIG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys Fluid Management SystemBoston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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